Book of Abstracts for the Conference

SCIENCE FOOD SOCIETY Parma, 18-21 September 2018

SUPPLEMENT PDF ISBN 978-92-9499-081-5

TM-01-18-903-EN-N

Manuscript completed in September 2018

Reproduction is authorised provided the source is acknowledged.

For any use or reproduction of photos or other material that is not under the EFSA copyright, permission must be sought directly from the copyright holders.

SUPPLEMENT Conference Sessions

Foreword

Conference programme

Where science meets society: Putting risk assessment in context

Environment

Human health

Nutrition

Biological hazards

Human health (continued)

Engaging with society

Managing evidence

Envisioning the expertise of the future

Staying relevant in a changing world

Poster session Foreword for the book of abstracts for the conference

On behalf of the organising committee, I am very happy to welcome all delegates, presenters and participants to the EFSA conference 2018 – Science, Food, Society in Parma.

The chosen motto “contextualising risk assessment” sets the stage for this exciting event.

In the upcoming days, researchers, risk assessors, social scientists, risk managers and stakeholders from around the world will gather to discuss issues pertaining to the complex interplay between science, food and society. We will tackle issues such as trust in science, the new frontiers in risk assessment and the unresolved challenges which the food safety and regulatory communities face. Together, we will develop scenarios on the future of food safety in Europe and beyond.

And we’ll do all this keeping into consideration the increasingly complex social and political context within which organisations like EFSA operate.

This book presents the abstracts of the conference as well as the biographies of speakers; it will serve as a useful guide to the subjects under discussion.

I hope that you will enjoy these three days in Parma!

Marta Hugas , European Food Safety Authority’s Chief Scientist Conference programme

18 SEPTEMBER 2018

19 SEPTEMBER 2018

20 SEPTEMBER 2018

Staying relevant in a changing world 08:30 - 13:00 | Plenary session | Plenary Room 10:40 - 11:10 | Coffee break | Eat&meet area Where science society: meets Putting risk incontext assessment 7 moderated paneldiscussion. context. witha sessionwillend The byrisk assessment, itinasocietal placing to restoring credibility the trustin ofand explore approaches thatcancontribute purpose risk Thissessionwill assessments. beabletoand rely onrobust fit-for- and to balance facts values and effectively whileriskhigh demand managers need a challengingadvice scientific time isin as proxies for differences invalues. Insuch politicised;scientificargumentsand serve discussions aboutrisks are often polarised opinion. Science isincreasingly mistrusted; influential than public inshaping facts world inwhich values are becoming more increasingly complex becausewe live ina policy and assessment hasbecome interplayThe between science, risk Putting risk incontext assessment Where science society: meets EFSA JOURNAL |SUPPLEMENT Barbara Gallani CHAIR Yann Devos RAPPORTEURS University ofGhent. the PhD inappliedbiologicalsciences from University the ofAntwerp,both from a holds and degree inenvironmentalsupplementary sciences has aMaster’s degree inbiology(ecology) a and Assessment for Release the ofTransgenic Plants’. He ‘Environmental Considerations for Risk/Safety drafting consensus the on document In 2015, Yann OECD the joined Steering Group ScientificInstituteDivision ofthe ofPublicHealth. worked BelgianBiosafety atthe Biotechnology and degree inadvanced systems. instrumentation education PGCE(physics sciences) and aMaster’s and degree inphysics, apost-graduate certificate in Consumers’ Organisation. Barbara aBachelor’s holds Telegraph. alsoworked She European atthe Fellowship onscience communication Daily atthe Commission aBAMedia and (DGSANCO) including asecondment to European the Consortium UKFood atthe and Standards Agency, Food Drink and Federation, British atthe Retail worked she Before EFSA, joining UKatthe inthe ,European Food Safety Authority ,European Food Safety Authority the public and private publicand the sector. professional experience, bothin 16years hashad and of Food Science Technology and fellowand Institute ofthe of Barbara isachartered scientist Cooperationand Department. Communication, Engagement Barbara Gallaniishead ofEFSA’s since previously and 2008, has beenemployed by EFSA risk He guidelines. assessment development the (GMOs) and of organisms modified genetically riskthe of assessment GMO Unitwhere isinvolved he in officer and team leader atEFSA’s Yann Devos isaseniorscientific

DAY 1 • 18 September Where science society: meets Putting risk incontext assessment 8 Victoria Villamar Tobin Robinson RamsayJames Université Libre deBruxelles, which in obtained she the decision making EUinstitutionsfrom and aMaster’sholds degree inEuropean law, EU workedshe European atthe Parliament. Victoria for Legalthe last3years. her Department Previously, 1999to positionofhead the holding of 2004, from worked European atthe Consumers’ Organisation VictoriaRelations. Before withEFSA, time her teamand leader for Stakeholder Institutional and strategic internal communications seniorofficer, deputy head ofUnitfor Inter-Institutional Relations, asstakeholder starting officer, in2004, joined she Victoria various hasheld positionswithinEFSA since bothadegreeobtained PhDinmicrobiology. and Cardiff UniversityHe graduated where he from Research, working onmicrobiological food safety. Readingat the Laboratory Institute ofthe ofFood worked started and hiscareer industry dairy inthe Sciencethe Strategy Hehaspreviously Department. for over 11years, including aperiod head asacting of responding to crises. Hehasbeenworking for EFSA food feed and chain, aswell aspreparation for identification ofemerging risks inthe European Birmingham University.Hispanic studiesfrom Leicester University degree aBachelor’s and in Master’s degree ininternational relations from well asfor industry. services financial the Hehasa EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority ,European Food Safety Authority ,European Food Safety Authority of EFSA 2020 strategic priorities. to implementation the support stakeholder engagement officers team ofinstitutionaland position, Victoria was leading a September Before 2018. this Cooperationand atEFSA since head Unitfor ofthe Engagement Victoria Villamar hasbeenthe place aprocess for early the of food feed, and putting and in approaches for risk assessment areathe ofnew harmonised and preparationadvice ofscientific in whereUnit, isinvolved he inthe Committee Emerging and Risks head ofEFSA’s Scientific Currently, Tobin Robinsonisthe Europeanthe Commission, as government and departments sector clients, including UK London for voluntary publicand communications consultant in worked James Before EFSA, asa Head ofcommunication unit. since 2011, where iscurrently he RamsayJames hasbeenatEFSA Bernhard Url SPEAKERS Silvio Funtowicz in-between uncertain the and new old,the The Science society? meeting and the evolving the and relation between ‘science’ and seems to beafair description current of the time, appear.’ (Prison Notebooks 1929–1935, Q3 p. 311).It interregnum agreat variety ofmorbid symptoms new the and old isdying beborn; cannot inthis crisis consists precisely‘The fact inthe thatthe Antonio onhistimes, Reflecting Gramsci wrote: https://en.wikipedia.org/wiki/Silvio_Funtowicz international conferences. scientific committee ofmany projects and editorial board ofseveral the publicationsand has lectured extensively participated and inthe technological risks, policy-related and research. He papers fieldofenvironmental inthe and Norway. ofnumerous author Heisthe books and Humanities (SVT) University atthe ofBergen, CentreII atthe for Sciences Studyofthe the the and (EC-JRC). Since February 2012 hasbeenProfessor he Research Centre European ofthe Commission Securityand Citizen ofthe Joint (IPSC)ofthe a PhDinveterinary medicine. graduated asveterinary doctor, medicine holds and 1993 to Bernhard 2002. control laboratory from ViennaMedicine, before afood running quality MilkTechnologyand University atthe ofVeterinary assistant professor Institute atthe ofMilkHygiene board. Previously, Bernhard spent5years had asan ofEFSA’s alsoserved asamember he management Health Food and Safety. From 2008 to March 2012, directormanaging Austrian ofthe Agency for University deCompostela. ofSantiago 1998 after 5-years her studiesinLaw atthe ,European Food Safety Authority ,University ofBergen joining EFSA, Bernhard was EFSA, joining BeforeAssistance Department. Assessment Scientific and 2012June as head Risk ofthe Bernhardmonths. EFSA joined in executiveacting director for 7 having servedas 2014, June executive director ofEFSA in Bernhard Url was appointed the Institutethe for Protection the 2011 was he ascientificofficer at UntilhisretirementEngland. in Universityat the ofLeeds, was1980s he aResearch Fellow Aires, Argentina. During the research inBuenos methodology teaching logicand mathematics, Silvio Funtowicz beganhiscareer

DAY 1 • 18 September Where science society: meets Putting risk incontext assessment 9 decision making inpolicy processes: relation ofthe models between science and understanding, we several canidentify conceptual normal science problem. lightofthisnew Inthe decisions urgent. lastfeatures These illustrate apost are values uncertain, indispute, stakes highand context, we are aware possibility ofthe thatfacts Today, science when isdeployed policy inthe rolethe ofscience hasalsodeveloped matured. and inherently difficult of resolution, the conception of come to berecognised ascomplex, more and legitimacy. As science-related policy issueshave for anew conceptual practical and of models morbid symptoms appear barriers ofthe aspart of governance for contemporary societies.The to justify, to functional longer no and legitimacy the emerging awareness isdifficult thatthisdistinction strictof their isan separation, whereas ‘new’ the ‘old’The here isrepresented by modern the ideal of which isrisk risk and assessment management). change role isinthe offacts values and (aninstance invested Anillustration inthem. ofthisongoing condition, personal societaland alsothe and stakes resultthe intimate oftheir relation to human the so clearly realms inthose by isnot chance, but lifestyles.diet and crisis Thatthe manifests itself onhealth,‘society’, inparticular environment, the • • • • Demarcation (possibility ofabusescience). choicethe isarbitrary (orsocio-political). hence and to extent some choice offramework, There conclusive isno scientific basis for the which becomes itbelongs, aprior policy decision. Even choice the scientificdiscipline ofthe to relevantthe scientificproblem to beinvestigated. of relevant practical hence issue,and framing the There are simple‘facts’ no thatresolve the actors have own their perspective values. and inputs to apolicy process inwhich aplurality of scientific information becomes many among one absencemisuse). Inthe ofconclusive facts, Framing (arbitrariness ofchoice possible and legitimisesdecisions. and policy decisions: precaution, which bothprotects science, there isanextra, normative, in element situations. Becauseofthisimperfection inthe can fail, leading to sometimes pathological policy. Progress control and beassumed cannot inthemselves,fully certain conclusive nor for discovered scientific that the arefacts neither information). Inreal policy processes, itis Precautionary inconclusive and (uncertain model perfectibility practice. and ofscience intheory perfection/ onanassumed vision, dependent of humankind. ‘technocratic’ Thisisthe limitstono material the moral and progress humans’ control over environment, their and power. There are limitsto no progress the of good;inmodernthe terms, truthspeaks to correct policy. Inclassical terms, trueentails the rigorous demonstrations, would determine Scientific (unproblematic),facts employed in (perfection/perfectibility). model ‘modern’ The EFSA JOURNAL |SUPPLEMENT Kevin Elliott valuesManaging inscience risk and assessment Science (edited withDaniel Steel, Routledge, 2017), Press, 2017), Current Controversies inValues and Introduction to Values inScience (Oxford University University Press, 2011), ATapestry ofValues: An Values inEnvironmental Research (Oxford Little Pollution Goodfor You? Incorporating Societal to scientific research. Hispublicationsinclude Isa that values play inscience ethicalissuesrelated and • and constitutionaland changes. challenge thatwillrequire institutional scientific, of governance. thisisagreat Implementing of extended involves participation anew form (desire for) power, isunchanged.model final The truthspeaking(claims to of) politicians’ the corethe ideal modern ofthe experts’ the model, politicalinterference.are protected However, from by stakeholders, orscientists problems are framed we seethatpolicy ismodified by precaution, relevantthe knowledge. different Inthe models, ‘local’, ‘ethical’ ‘practical’, or‘spiritual’, are of part contributions,Their described sometimes as process of an extended aspart peercommunity. critics creators and knowledge inthe production open publicdialogue.Citizens become both scientific demonstration is replaced by thatof relevantof the knowledge. ideal The ofrigorous activity oftechnical experts)isincluded part asone for providing advice. Science (understood asthe to defend ofaccredited amonopoly expertise policythe process, itbecomes ever more difficult imperfections deployment inthe ofscience in communities). Given above-mentioned the Extended (extended participation peer advocacy oncontentious policy issues. pronouncements they when inpartisan engage statusasanillegitimatetheir validation oftheir authority the using of it prevents scientistsfrom accountability rests withpolicy makers. In addition, threating itsintegrity. Italsoensures thatpolitical politicalinterference the protecting science from in which itisused,advocated asameans of providingindividuals) science, the those and clear demarcation between institutions(and the conclusions. dataand ofmethods, shaping A of whatisoffered, through and selection the shows thatthiscontext canaffect contents the owninstitutions withtheir Experience agendas. policy process are produced by peopleworking in scientific The evidence advice and usedinthe ,Michigan State University research focuses roles onthe whose He isaphilosopher Michigan State University, USA. ofPhilosophy at Department Fisheries Wildlife, and the and College, of Department the inLymanappointments Briggs Professor withjoint Kevin Elliott isanAssociate

DAY 1 • 18 September Where science society: meets Putting risk incontext assessment 10 Philip Macdonald to decision-making support reliableand information for risk assessment problemUsing formulation to relevant identify promote reflection, engagement. and openness through bemanaged should assessment to efforts Instead, Iwillargue thatvalues inscience risk and about values result and inconflict distrust. and to undertake thissooften prevent reflection needed valuethese influences canbe removed, efforts and often amistake. Itistypically unrealistic to thinkthat Iwillargue judgements, these influencing thatthisis socialvalueethical and considerations from Whileitistemptingjudgements. to to try prevent environment are to subject numerous value topics related to food safety, agriculture the and Scientific research and on risk assessments conflicts ofinterest in research. value-laden information, strategies and for handling responsibilities communicate ofscientistswho communicatescientists who aboutvalues, ethical havearticles explored publicperceptions of University Press, 2017). Hisrecently published in Science (edited withTed Richards, Oxford Exploringand Inductive Risk:Case StudiesofValues models formodels herbicide resistance. University inOttawa, where I worked onmolecular My graduate studies were completed atCarleton herbicide tolerant transgenic plants, then animals. 10 years inaresearch laboratory, first working on I have come to regulatory the environment after Annex Protocol. 3onrisk Cartagena ofthe assessment thatdevelopedManagement Guidance for further Technical Expert Group onRiskAssessment Risk and Canada asatechnical Ad-Hoc expertonthe nanotechnology synthetic and biology. Irepresented approaches to emerging technologies such as based plantbreeding technologies regulatory and modern biotechnology, application ofgenomic the environmental risks posedby plantsmodified by internationalin nationaland discussions onthe represented Canadian the Food Agency Inspection regulatory scientific and community. Ihave also workshops capacity and to building international the risks posedby GMcrops, delivered risk assessment of scientificissues related environmentalto the I have acted CFIAspokesperson asthe onanumber how and genomics tools these caninform policy. relatedespecially those to applicationsof the EFSA JOURNAL |SUPPLEMENT and diagnostic initiatives, diagnostic and Agency’s plant health research Canadian Food Inspection scientists thatcoordinate the lead and agroupsupervise of In my current position,I relatedmostly to biotechnology. in government regulation, I have worked for nearly 20 years , Canadian Food Agency Inspection David Spiegelhalter over risk science-led oughtto assessment beclear. mistakes are recognised, superiority the ofpolicy-led purpose the and Once ofrisk these assessment. mistaken nature assumptionsabout the ofscience instead ofscience. trends These are based on to appear to bemaking decisionsbased onpolitics reluctance the and assessment, ofrisk managers prior definition ofpolicy introduces biasinto risk forneed scientific idea the hypotheses, that proponents continuing the ofbig dataquestioning over policy-led include These risk assessment. several trends appear to befavouring science-led consideration Unfortunately, ofsocietalneeds. show statisticallysignificanteffects,not after careful inresponse posthoc be made to whatever variables controversial because regulatory policy appears to decisions based onsuch practices are likely to be be spurious. Thisleads to asecond problem inthat biological relevance ofwhich some and are likely to significant differences thatmay beofunknown decision-making inresponse ismade to statistically risk hassignificantdisadvantages. assessment First, differences revealed by profiles. the “Science-led” policy decisionsare in response made to effects or thatcomparemethods numerous variables and seeks to replace. This approach often usesprofiling existing acceptable activity new thatthe activity an hypothesis effect ofno change orofno from Scientifically, such characterisation isa test ofanull consequencesof the ofaproposed activity. thatseeksassessment exhaustive characterisation risk isincontrast assessment to risk “science-led” risk the whether isacceptable). This“policy-led” outweighthat opportunities risks (i.e., assess (i.e., probability the and opportunity), assessthe probability value and ofany effects beneficial of any harmful effects (i.e., risk), assessthe the science canestimate probability the severity and “harm”, “benefit”, and “acceptability” are inplace, proposedof the activity. Once definitionsof of whatwould beregarded effects asbeneficial statements ofpolicy asthey encompass definitions provided are by also opportunities activity; the howand risk opportunities willbeoffsetagainst regarded asharmful effects proposed ofthe activity because they require definitionsofwhat would be are“Unacceptable” statements “risk” and ofpolicy scienceand in“science-based”risk assessment. correct the establishing relationship between policy acceptabilityabout the ofrisk have avitalrole in seen asirrelevant for Hypotheses risk assessment. unrelated to acceptability the oughtto ofrisk, be weak tests hypotheses, ofthese ortest hypotheses datathatprovide hand, other Onthe assessment. hypotheses may beregarded asrelevant for risk acquired datathatprovide rigorous tests ofsuch poseunacceptablewill not Existing risk. ornewly cultivating GMcrop aparticular pesticide, orusing takeHypotheses form the activity, thatthe such as a proposed activity oughtto bepermitted. risk managers making decisions aboutwhether testsand hypotheses ofthose thatare usefulfor Problem formulation devising isthe ofhypotheses , University ofCambridge

DAY 1 • 18 September Where science society: meets Putting risk incontext assessment 11 Fern Wickson Areassessment: we there yet? Responsible research, innovation &risk spare Fern time, enjoys hiking, snowboarding, and diverse conceptualisation ofvalues innature. Inher Biodiversity Ecosystem and (IPBES) Services onthe group Intergovernmental ofthe Panel on recent hasalsoserved inthe She expert working Study ofNew Emerging and Technologies (S.Net). past President international ofthe Society for the Norwegian Biotechnologythe Board Advisory a and work.policy of isanexpert member She advisory performing ofGMOsand assessment arange of coursesbuilding around world the onbiosafety experience inorganizing teaching and capacity technologies. Beyond research, her Fern alsohas environmental governance nano- and ofbio- programmes,funding improving and the responsible research innovation and inEuropean agricultural biodiversity conservation, advancing agriculture, integrating ex insitu and of situmodels systems-based thinking for sustainablecultures of current research projects are such onsubjects as: innovation resilient and futures. socio-ecological Her ethics, sustainableagriculture, responsible research thatspecificallyaims advanceto ecological politicalscience,and performs she transdisciplinary emergingand technologies. With aPhDinbiology philosophy inpursuit ofgood governance ofnew integrates environmental science, policy and Wipeout. televisionepisode ofthe programme game Winter Statistical Society. In2011 seventh came he inan statistics. For 2017–2018 isPresident he Royal ofthe wasand knighted in2014 for to services medical was elected FRSin2005, awarded anOBEin2006, award-winning ‘Climate by Change Numbers’. He ‘Tails you Win: Science the ofChance’ the and risk issues.Hepresented BBC4 the documentaries communication, isaregular and commentator on others, organisations advises onrisk society. Hegives many presentations to schools and statisticalevidenceand are discussedin taughtand EFSA JOURNAL |SUPPLEMENT , Genøk of ecological care, work her (RootS). Committed to apolitics Sustainable Biotechnoscience collaborative for Responsibleand transdisciplinary the Norway, where coordinates she Centre for Biosafety inTromsø, Researchand Leader atGenøk Fern Wickson isaSeniorScientist improve way the inwhich risk Communication, works he to EvidenceRisk and WintonChair ofthe Centre for Cambridge University as and, Fellow ofChurchill College at Understanding ofRiskand Professor for Public the David Spiegelhalter isWinton Frederic Simon about high-level politics. environment whilecontinuing to write regularly leads EURACTIV’s coverage onenergy the and energy climate and transport, legislation.Henow future. plan steps to move help uscloser to thatgoal inthe are to achieving thatvisiontoday, asetofaction and requires,assessment adiscussionofhow close we development ofavisionfor whatresponsible risk to audience the to collaboratively inthe engage practices. close talk willthen The withan invitation addressed and handled through risk assessment open access, inclusion responsiveness and are how principles such equality, ofgender asthose keysthe ofRRI.For dimensions and example, day risk practices assessment measure upagainst include ofhow anassessment current ofthe some it more accountable. and sociallysound Thiswill toefforts contextualise risk make and assessment different these approacheslearned to RRIfor from talktoof the reflect lessonsthatcanbe onthe national authorities. remainder usethe Iwillthen adopted UKand the by some by from academics inclusion, reflection, responsiveness) asarticulated approach (i.e. AIRRdimensions ofthe anticipation, science alternative the education,ethics)and (i.e. gender, openaccess, societalengagement, policy keys approach European ofthe Commission practice. Thiswillinclude anoverview five ofthe have emerged itin for enacting and defining different ofthe that some of RRIand frameworks will beginby presenting overarching the concept Horizon2020 programme. funding I Inthistalk, now across-cutting being European inthe theme innovation. Thisisevidenced, for example, by RRI advance more forms ‘responsible’ ofresearch and has ledto anincreasing to need emphasisonthe This contradiction setofchallenges the and itposes values fails and to actively withcitizens. engage social sciencewhen operates atadistance from thatsignificant and resistance isencountered as many problems asthey are introduced to solve recognition thatnew technologies often create progress currently exists anunsettling alongside innovation isinherently desirable for necessary and Innovation’ master ongoing (RRI).The narrative that perspectivethe of‘Responsible Research and for contextualisation the ofrisk from assessment This talkwillfocus onchallenges opportunities and ofNorway Peaceful calledThe north in the Wild. yoga teacher meditation and own runsinher and studio totrying grow own her food. isalsoatrained She ,EurActiv financial affairs,financial agriculture, telecoms to economic and policy topics, ranging from covered aboutevery ofEU aspect 2003 asareporter hassince and Frédéric EURACTIV joined in specialisedinEUaffairs.media EURACTIV, leading the online Frédéric iseditor Simon at

DAY 1 • 18 September Where science meets society: Putting risk assessment in context Where science meets society: Putting risk assessment in context

Frédéric is also Brussels correspondent for France24, Julie Girling , European People’s Party the 24/7 international TV channel. Mr Simon graduated in journalism from Brussels University (ULB) in 1998 and holds a Master’s degree in EU Julie Girling was elected as a politics from the Institut d’Etudes Européennes Conservative Member of the European Parliament for South (IEE) in Brussels: West England and Gibraltar in

2009 and was successfully 1 • 18 September DAY • since 2008: Brussels correspondent, France24 re-elected for a second term in • since 2007: Editor, EURACTIV.com 2014.

• 2003–2007: Reporter, EURACTIV.com She is currently sits on the Committees for Environment, Public Health and Food • 2002: Master’s degree, Institute of European Safety and for Women’s Rights and Gender Equality. Studies (IEE), Brussels She also sits on the Delegation for relations with South • 1998: Graduated in journalism and East Asia and has previously served as Chief Whip for communication from the Université Libre de the Conservatives in the European Parliament. Bruxelles (ULB). Formerly a member of the European Conservatives and Reformists Group (ECR), she has recently moved to become a member of the European PANELLISTS People’s Party Group (EPP), the Conservatives in the European Parliament were members of this group Klaus Berend , European Commission until 2009, when the ECR Group was created.

During her time in the European Parliament she Dr Klaus Berend joined the has worked on a number of important legislative European Commission in 1994 files, covering areas such as air quality, emissions, and is currently Head of Unit in food safety, reform of the Common Agriculture and the European Commission’s Fisheries Policies, biodiversity, chemicals and animal Directorate-General Health and welfare. Mrs Girling has recently been a rapporteur Food Safety, responsible for the for both the ETS Phase IV and the Aviation ETS files. implementation of the Pesticides and Biocides legislation.

Piro to that he was Head of Unit in the European Monique Goyens , The European Consumer Organisation Commission’s Directorate-General Internal Market, Industry, Entrepreneurship & SMEs, in charge of the As Director General of BEUC, implementation of the EU Regulation concerning Monique represents 43 the Registration, Evaluation, Authorisation and independent national consumer Restriction of Chemicals (REACH). associations in 31 European countries, acting as a strong Previously, he was Head of Unit in DG Enterprise consumer voice in Brussels, & Industry, responsible for EU legislation on the ensuring that consumer interests Classification, Labelling and Packaging of substances are given weight in the and mixtures (CLP), Good Laboratory Practices (GLP), development of policies and detergents, fertilisers, drug precursors, explosives raising the visibility and effectiveness of the and pyrotechnic articles. The Unit also dealt with the consumer movement through lobbying EU sustainability and competitiveness of the chemicals institutions and media contacts. industry in the European Union. As a consumer expert and advocate and, on behalf Earlier, he was Deputy Head of Unit in the of BEUC, she is currently a member of the EU Commission’s Directorate General for Environment, High Level Forum for a Better Functioning Food Unit Biotechnology & Pesticides, where he Supply Chain and a delegate in the Consultative coordinated the work concerning biocides, Commission on Industrial Change of the European plant protection products and the Community’s Economic and Social Committee. She is an effective participation in the Rotterdam Convention on Prior member of the Euro Retail Payments Board. She Informed Consent (PIC). has also been appointed to the expert group on He studied chemistry at the universities of ‘fake news’ (2018) and in the expert group on ‘trade Heidelberg, Freiburg, and Stanford, and obtained agreements’ (2018–2019). She is member of the a PhD in polymer chemistry from the University of Advisory Group of Transparency International EU Freiburg (Germany). and of the European Advisory Board of the Open Society Foundations.

In her capacity as BEUC Director General, Monique is currently EU co-chair of the Transatlantic Consumer Dialogue (TACD) a network of EU and US

12 EFSA JOURNAL | SUPPLEMENT Where science meets society: Putting risk assessment in context

consumer organisations, and she also represents promoting full transparency within the European BEUC at Consumers International, the international Institutions and the participation of civil society consumer organisation. organisations in European decision-making processes. Jorgo Riss has a master’s degree in Apart from championing consumers’ rights, political science, and worked as a journalist and Monique’s passions/challenges are her family, cooking academic before joining Greenpeace. Greenpeace is for friends and long walks with her golden retriever. present in 55 countries world-wide and is funded by about 3 million individual supporters. 1 • 18 September DAY

Bjorn Hansen , European Chemical Agency

Bjorn Hansen is ECHA’s Executive Director. He is ECHA’s legal representative, in charge of the day-to-day management and all staff matters. Bjorn is ECHA’s second Executive Director with a mandate running from 1 January 2018 to 31 December 2022. After a post-doc in probability theory in Germany, he joined the European Commissions in 1991. Working first at the European Chemicals Bureau at the JRC in Italy and then from 2003 in the Chemicals Unit of DG Environment in Belgium. There Bjorn became Head of Unit in 2012. He already spent 1 year in ECHA in 2007–2008 as Director of Operations. Bjorn was involved in the development of REACH and CLP from their very early days. He has been involved in international chemicals work since 1991, highlights being elected chair of the OECD Working Party on Manufactured Nanomaterials and having chaired several contact groups at three consecutive UN triple COPs.

Jorgo Riss , Greenpeace

Jorgo Riss has been the Director of the Greenpeace European Unit since 2003. Mr Riss and his team analyse the work of the EU institutions, expose deficient policies and laws, and challenge decision-makers to implement progressive solutions in such areas as climate change, energy, forests, trade, chemicals and sustainable agriculture. The European Unit works closely with the Greenpeace Research Laboratories, based at the University of Exeter (UK), which provide scientific advice and analytical support. Mr Riss is also a co-founder and a member of the steering committee of the Alliance for Lobbying Transparency and Ethics Regulation in the EU (ALTER-EU), a coalition of over 200 public interest groups and trade unions concerned with the overwhelming influence of corporate lobbyists on the political agenda in Europe, the resulting loss of democracy in EU decision-making, and the weakening, when it is not full obstruction, of social, environmental and consumer-protection reforms. He is also a member of the board of Civil Society Europe, which brings together 27 European networks of civil society organisations (CSO) that work for the renewal of European Democracy,

13 EFSA JOURNAL | SUPPLEMENT 14 Advancing risk science assessment -Environment Environment Advancing riskassessmentscience predictive ERAs willbeexplored. approachesand for more integrated and ofnew usefulness the In addition, tools useful inconducting such assessments. typesthe of information thatwillbe willbeusedto formally ERA, identify considerations into for planning the an incorporating scientific legal,socialand formulation, which isaprocess for array of products horizon. onthe Problem foralso discussERAneeds diverse the appliedinpractice,being thissessionwill contextIn the ofemerging technologies risk management. ecosystem concept services to ERAand challengesand involved the inapplying This sessionwilladdress opportunities the acrossservices different spatial scales. may delivery ofecosystem the impact understanding ofhow activities specific interactions, their and lack and of complexities ofecosystem components practice canentailchallenges dueto the decision-making, putting concept the into muchholds promise for environmental ecosystemWhile the concept services environment for future generations. maintains ahealthy resilient and natural ecosystems, for and ensuring thatsociety for evaluating provided services the by provides acomprehensive framework goals. ecosystem The concept services directly transparently and to protection ecosystems, asthiswould relate ERA healthy functioning derives from which are thathumankind benefits the considerationthe ofecosystem services, avenue to advancement the ofERAis affected by anactivity. Apotential biodiversity ecosystems, and may be environment,it isthatthe including protection by evaluating how likely plays role inenvironmental animportant Environmental risk (ERA) assessment EFSA JOURNAL |SUPPLEMENT Silvia Pieper Anthony Hardy CHAIRS higher tierriskhigher steps. assessment ofchemicals impact the interrestrial ecosystem at expertise covers characterisation the inparticular of provision and support ofecosystem Her services. consequences onthe and ofbiodiversity lossfor the exploring ofpollutantsonbiodiversity impact the Residues (PPR). interest Silviahasaparticular in EFSA Panel onPlantProtection Products their and reptiles). ofthe vice-chair and isamember She soilorganisms,arthropods, amphibiansand 2011 in several working groups (non-target hasbeeninvolvedof pesticides.She withEFSA since Plants for 5years. chaired Commission’s the Scientific Committee on EFSA’s in2003. establishment Before thathe Residues (dealing withpesticides) for 9years from EFSA Panel onPlantProtection Products their and Scientific Committee, Professor Hardy chaired the 40 years. Before his6-year term asChairofEFSA’s ecotoxicologyassessment, food and safety for nearly been involved international innationaland risk diseases,and food and safety. Professor Hardy has ofagricultural management and assessment pests environmental ofchemicals, impact risk the agricultural pesticidesonwildlife, wider the has worked offarming impact onthe and Science Laboratory for 33 years before retiring. He Environment, Food Rural and Affairs itsCentral and ,German Environment Agency

, Formerly ofEFSA’s Scientific Committee the Department for Department the Agriculture, Fisheries Food, and worked UK’s inthe of Ministry Aberdeenand Universities. He chemist withdegrees atOxford environmentalbiologist and Committee, Tony Hardy isa Chair ofEFSA’s Scientific An external former expertand environmental risk assessment Environment Agency inthe worked German atthe soil ecology. For 10years, has she Technische Universität Berlin in received PhDatthe her terrestrial ecosystems. She ecotoxicologist withafocus on Silvia Pieper isabiologistand

DAY 2 • 19 September 15 Advancing risk science assessment -Environment Juliane Kleiner Juliane Catherine Ganzleben biology from the University the ofMarburg. biology from University aPhDinhuman holds ofGiessen,and the Master’s degree innutritional sciences from food ofthe safetysupport programme. hasa Juliane responsible for and scientificmanagement the ILSI Europe private inthe sector asseniorscientist, worked University atthe ofMarburg, at then and Executive Director Office. she Before EFSA, joining seniorsciencebecame coordinator inEFSA’s for Regulated Products. InSeptember she 2016, 1.5yearsanother head asacting Department ofthe Coordination for 1.5years, servedfor then and Directoratethe ofScience Strategy and After Nutrition ledthe she Unit. took thatshe over International Institute for SustainableDevelopment. Europeanthe Environmental Bureau the and hasalsoworkedShe for NGOsector, the including Tokyo University the aDoctorate and ofOxford. from United NationsInstitute ofAdvanced Studiesin the chemicals. Catherine hasapost-doctorate from multilateral environmental agreements on Geneva, delivering technical of assistance insupport Nations Institute for Training Research and in Catherinethat, worked for two years United atthe health issuesto international organisations. Before delivering contracts onenvironment public and was aSeniorPolicy Advisor atMilieuLtd inBrussels, health well-being. and From 2008 to 2013, Catherine dynamic between ecosystem human and services EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority Committee. From 2008 to 2013 a team leader for Scientific the Contaminants as then and Unit, inthe starting EFSA since 2004, hasworked She Department. at Scientific Assistance EFSA’s RiskAssessment and head acting has beenthe of Since Kleiner Juliane July2018, chemicals, aswell broader asthe including and airpollution,noise environmental risks to health, work onarange of isresponsibleShe for strands of European Environment Agency. Environment Health and atthe Head Group ofthe on Dr Catherine Ganzlebenisacting

, European Environment Agency Ciro Gardi Yann Devos RAPPORTEURS Reinhilde Schoonjans Authority Munich. patent European the attorney Patent from Office in InOctoberGhent. 2005, qualifiedas she European University the of aPhDfrom biologist holding endocrine active substance. Reinhildeis amolecular protection goals, identificationof and epigenetics cloning offarmed animals,environmental State University. between University the Washington of Bolognaand hasaPhDincropBologna, and science shared University the in developing of countries from international cooperation intervention and politics degrees inagriculture, plantprotection, and ecosystemand provision. service Ciro Master’s holds interactions between soilquality management, land knowledgehas in-depth ofagricultural systems and ,European Food Safety Authority ,European Food Safety Authority Global SoilPartnership (FAO). He Currently, ofthe isamember he OECD several and Bank, NGOs. European Commission, World expert forindependent the a consultant served asan and was he Before Unit. EFSA, joining EFSA’s PlantHealth Animal and Ciro Gardi isascientificofficer at Seebiography p.7 also works ontopics related to Member States delegates. She chairs Network Nano the withEU Group onnanomaterials and coordinates expert Working the Emerging Risks She Unit. Scientific Committee and scientific officer at EFSA’s Reinhilde Schoonjans isa

, European Food Safety

DAY 2 • 19 September 16 Advancing risk science assessment -Environment Lijbert Brussaard Lijbert ecosystemmultifunctionality and services elusiveThe links between biodiversity, SPEAKERS Franz Streissl quantitatively linking biodiversity, multifunctionality normative nature concepts. ofthe ofsome As a result, contributions to people). Achallenge ontop isthe nature; culture/ local knowledge focus onnature’s from (utilitarian focus peoplederive benefits onthe multifunctionality) ecosystem and services multifunctionality; ecosystemfunction service groups),functional multifunctionality (ecosystem used to express biodiversity traits; (genes; species; there isconsiderable difference metrics inthe bemeasuredcannot directly field.Hence, inthe environment,the they share fact the thatthey exploiting nature conserving and for and protecting ecosystemand for services understanding, conceptsof the ofbiodiversity, multifunctionality Although there isbroad consensus usefulness onthe Wageningen University. environmental sciences (soilbiology)from Amsterdam, aPhDinagricultural holds and and VUUniversity,biology (ecology) cumlaudefrom Netherlands. hisMaster’s Heobtained degree in Institute for SoilFertility Research atHaren, The previously users.land Lijbert worked then atthe makingand itoperational for farmers other and scientific underpinning ofthe concept ofsoilquality recent Hismost landscapes. focus isonthe decisionmakingand by actors inagricultural scientific knowledge may inform planning land-use mediatedservices by how soilbiota,and the is onphysiology ecology. and University ofVienna, focus the and ofhiseducation the workshops. aPhDinZoology Heholds from presentationsreports, atconferences and contributed to alarge numberofgovernmental EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority straight soilbiologyto ecosystem interest hasbroadened from Netherlands. Over years, the his University Research, and The retirement (2016) atWageningen guest worker since his then 1988and Biology from position ofProfessor ofSoil Brussaard the held Lijbert Europeanat the level. Hehas risks ofpesticidesatnationaland ofenvironmentalassessment was he past, the responsible for for pesticiderisk In assessments. developing guidance documents focusThe ofhiswork ison officer inEFSA’s Pesticides Unit. Franz Streissl isaseniorscientific ,Wageningen University &Research Key words: biodiversity, multifunctionality, ecosystem services Ecosystems &Environment, 239:265-273. approach to ecosystem insoil.Agriculture, functioning 2017. Acommunity trait-based Sechi V, deGoedeRGM,Rutgers M,Brussaard LandMulderC, and Biochemistry, 120: 105-125. Soilquality 2018. –acriticaland Brussaardreview. L, SoilBiology Kuyper TW, MäderP, PullemanM,Sukkel W, van Groenigen JW GeissenV,Goede R,Fleskens L, CreamerBünemann EK,Bongiorno BaiZ, DeDeyn,de G, RE, G, OxfordServices, University Press, Oxford, UK,45-58. and van derPutten WH (Eds), SoilEcology andEcosystem Behan-Pelletier V, Herrick JonesH,RitzK,SixJ, JE, Strong DR In: Wall DH.,Bardgett RD, Ecosystem 2012. Brussaard L, provided services by thesoilbiota. References Wayne RMunnsJr of regulated stressors risk and assessments management of including ecosystem inrisk services for implications and Opportunities for Science ApplicationsInternational Corporation. Division Manager, Assistant and Scientist, Vice President Before USEPA joining in1995,Wayne was aSenior consideration ofecosystem indecision making. services has authored several papers promoting the Population-Leveland Ecological and RiskAssessment, Environmental Decisions Support to Socio-Economics Integration ofEcological RiskAssessment and & Francis books Valuation ofEcological Resources: policy decisions.Wayne and co-edited 2008 the Taylor groups to advance to methods inform environmental interagency international and panels working and hasservedonanumberof and risk assessment, integrationon the ofhumanhealth ecological and Group. World the Hehasadvised Health Organization Ecological RiskAssessmentChemistry’s Advisory SocietyChair ofthe ofEnvironmental Toxicology and ofUSEPA’smember RiskAssessment Forum, apast ecological and services, Wayne risk assessment. isa examples from soil quality assessment. soilquality assessment. examples from exclusively not mainly-though art, of the -using facethe ofmultiple stressors. Iwilladdress state the of (desired) ecosystem in services and functioning economicand level production the and functions; between between and functions ecological services; redundancy ofbiodiversity; synergies trade-offs and also evidenced by literature the onfunctional challengesThe oflinking three the concepts are ecosystemand straightforward. isnot services population modelling, ecosystempopulation modelling, fieldsof isanexpertinthe he ecologistAn aquatic by training, Narragansett, USA. Island, Rhode Research Development) and in Ecology Division(Office of Protection Agency’s Atlantic USEnvironmentalof the Wayne Director R.Munns,Jristhe

US Environmental Protection Agency

DAY 2 • 19 September 17 Advancing risk science assessment -Environment Valery EForbes stressors approach to risk ofregulated assessments ecosystem the inapplying Challenges service management Key words: ecosystem risk services, assessment, 13,62–73.Assessment andManagement, Integratedassessment andmanagement. Environmental M andvon Stackelberg Ecosystem K,2016. inrisk services Munns WR Jr, Poulsen V, GalaW, Marshall SJ, Rea AW, Sorensen 522–528. 12, Management, risk Integrated assessment. Environmental Assessment and 2015. Ecosystem asassessmentendpointsfor services ecological Crk T, Ferreira Davis C, Mahoney Jordan MandBarron G, S, M, Munns WR Jr, Rea AW, Blake-Hedges L, Suter, L, GWII,Martin References regards. inthese help environmental publichealth and protection can society ESconcept about the itsvalue and to protection goals. Broadly to based efforts educate inhowand ESinpoliciesand institutionsadapt relevant to decisionsare quantified, identifiedand improvements are ways inthe needed thatES for avariety ofregulatory programmes. Inaddition, inRA endpoints assessment including ES-based require procedural constructs guidance and for largely unverified. Realisation will benefits ofthese so ofdoing benefits aboutthe remain assertions remain relatively scarce. As aresult, many ofthe decisionmaking,in RAand applications actual developing specificapproaches for including ES Although progress some towards hasbeenmade consistentand environmental protection. programmes; (6)lead and to more comprehensive horizontal integration ofpolicies,regulations, and health ecological and risk (5)facilitate assessment; quality standards; (4) enableintegration ofhuman operational protection goals environmental and (3)inform actions; policies, and derivation the of involvedof trade-offs inenvironmental decisions, decisions based (2)articulate onthem; benefits the enhance transparency the can: (1) ofRAresults and incorporation inRA endpoints ofESasassessment regulated stressors. Ithasbeenasserted thatthe risk risk (RA)and assessment of management nature’s contributions to humanwell-being in fora comprehensive considering framework ecosystemThe (ES)concept services canprovide environmental focus withparticular management research extends across quantitative ecology and Environmental, Spatial Socialand Forbes’ Change. where was she founding of Head Department ofthe EFSA JOURNAL |SUPPLEMENT ,University ofMinnesota Roskilde University inDenmark, more thantwo at decades Nebraska-Lincoln spent and Sciences University atthe of Schoolof the of Biological Previously, servedasDirector she Universitythe USA. ofMinnesota, College ofBiologicalSciences at Valery Forbes isDean ofthe management, valuationmanagement, Key words: ecological protection goals, mechanistic models,risk challenges canbeaddressed. provideand suggestionsfor some how these ecosystemin applying for services risk assessment provide anoverview mainchallenges ofthe of some appropriate to methods undertake this.Thistalkwill ecosystem canbevalued services most the and there are debates ongoing over degree the to which linkages withconfidence. canbemade addition, In wellmechanistic, tested accepted and sothatthese urgent for need quantitative thatare models robust, forof importance there risk assessment, isan outcome pathways to to linkthese consequences measure stressor useofadverse the and impacts of invitro high-throughput and techniques to developmentemphasis onthe implementation and data to ecosystem delivery. service With growing that linkecotoxicological exposure effects and thereservices, for isaneed quantitative approaches onecosystemchemicals humanactivities other and deliver. To effectively predict of impacts the ecosystem onthe populations and they services translates into onservice-providing impacts toxicity ofregulated stressors to test species there are widegapsinknowledge ofhow the attention inrisk ofregulated assessment stressors, ecosystem are services increasingly gaining optionscanbeassessed.Althoughmanagement different among sothattrade-offs on services approachesand thatcanputappropriate values groupsand oforganisms) to delivery, service to chemicals by ecological entities(i.e. organisms approaches thatare ableto translate responses theredone, to willbea need develop quantitative a new way whatwe have ofarticulating always However, to bemore for thanjust thisframework for riska more management. robust framework onecosystemimpacts they services, canprovide outputsofriskthe canbelinked assessments to ecological To risk assessment. extent the that advantages over traditional approaches usedin ecosystem delivery offers service anumberof Formulating ecological protection goals in bodies. industry and providesand advice to awiderange ofgovernment editorialthe boards ofseveral international journals University ofNew York atStony Brook. serves on She State the marine environmental science from in coastal oceanography amaster’s and degree in ecological received She risk assessment. adoctorate effects oftoxic chemicals systems, inaquatic and on populationecology fate modelling, and and

DAY 2 • 19 September 18 Advancing risk science assessment -Environment Anne Alix Anne systems casestudiesonpesticidesinagricultural from forassessment regulated stressors: Learnings Ecosystem environmental services-based risk study, isbuilt approach same onthe compared and agricultural options(Deacon etal.,2016). second The bringing scenarios additional involving alternative refines interpretation the ofthe risk assessment by contextin the production oftheir conditions, and illustrates how datawere collected interpreted and performed intomato production farms inItaly, analysis thatusesESasmetrics. first The study, risk process assessment holistic data canfitina illustrate how datagenerated conventional inthe contextin the ofrisk for assessment pesticides,to This presentation offers two casestudies,developed (Maltby etal.,2018). decisionmakingthe process) research further need risk the and assessment ofanthropocentrism in complexitybut alsothe thismay bring into arisk costs valuation developments, ofthese ofES, ES, tools to convert conventional ecotoxicity testing to means to address challenges the identified(i.e. approachesES-based inrisk the assessments, community ofadvantages challenges and of While there isconsensus scientific withinthe CARESdiscussed inthe project (Maltby etal.,2018). advantages butalsochallenges, which have been risk approaches assessment ES-based presents (e.g. Munnsetal.,2016). development The of 2016) risk and paradigms assessment goals (EFSA, incorporate ESconcepts protection defining when regulatory authorities inEurope beyond and to between environment. their and them Thisled ecosystems, inthe living to interactions the ESarelandscapes. inherently linked to species the maintenance, wildlife enjoyable habitatsand food production, water purification, soil fertility of agroecosystem, ESprovide resources for of ecosystems to humanwellbeing. case Inthe Ecosystem (ES)describe Services contributions the for Europe MiddleEast Africa. and is now Regulatory Affairs risk and leader management as European Regulatory Leader. RiskManagement She monitoring. Dow joined Anne AgroSciences UKin2011, measures for ofpost-registration pesticides,and wasshe incharge ofrisk implementation the mitigation PlantProtectionPlacing Products Market, onthe where deputythe head for Section ofthe Regulationand French atthe management ofAgriculture Ministry as Food (AFSSA). linked She risk to assessment risk Ecotoxicology French unitatthe Agency safety onthe of EFSA JOURNAL |SUPPLEMENT ,DowDuPont as a head of the Environment and as ahead Environment ofthe and Agronomy (INRA)in2001, then and National Institute onResearch in an ecotoxicologist French atthe environmental risk as assessment France, Rennes, in2000. joined She vegetable crops University atthe of Integrated Pest in Management earnedAnne aPhDinBiologyand Management, 12(3),522-528.Management, risk Integrated assessment. Environmental Assessment and Ecosystem asassessmentendpointsfor services ecological FerreiraDavis C, Mahoney Jordan M,andBarron G, S, 2016. MG, Munns WR, Rea AW, Crk Suter T, Blake-Hedges GW, L, L, Martin chemicals. Science oftheTotal Environment, 621,1342-1351 ecosystem approach services to ecological risk assessmentfor Advantages andchallenges associated withimplementingan Maltby Van L, denBrink PJ, Faber 2018. JHandMarshall S, everywhere. Science oftheTotal Environment, 573: 1422-1429. ecosystem andbiodiversity: services we can’t have itall andMaltby Food 2016. production, ThomsonA, L, Holt AR,AlixA, 4499, EFSAservices. Journal 14, 50pp. inrelation toassessment atEFSA, biodiversity andecosystem specific protection goals;options for environmental risk EFSA 2016. Scientific Committee;EFSA, Guidance to develop 739. chlorpyrifos.insecticide Science oftheTotal Environment, 505,732- management decisions:casestudywithSpanishcitrusandthe and Andrews P, 2015. Integrating ecosystem into services risk NicoletteDeacon Norman S, S, J,Greene Osborn ReubG, G, R, 12(4),Assessment andManagement, 801-810. use intomato production inItaly. Integrated Environmental case studywiththesoilfumigant1,3-dichloropropene andits ecosystem into services crop protection andpestmanagement: Nicolette J, Rockel M,Burston P, Integrating andQuadri 2016. G, Knowles WheelerJ, Tescari S, Deacon AlixA, S, Alvarez E, L, References Marie Stenseke Ecosystemand (IPBES) Services Science-Policy Platform onBiodiversity approachthe Intergovernmental ofthe Valuing nature’s contributions to people: been carried out inaninterdisciplinary context and perspective. work Heracademic has predominantly asocialscience from management landscape concerns biodiversity, nature conservation and Gothenburg, Sweden. Professor Stenseke’s research the focusthe follow-up ofthe project. also identifiedduring the willbe and CARES project, clarity transparency. and mainchallenge Thisisthe tomethods compare discussESvalues and with conventional risk aswell into assessment as ES, illustrate guidance for need to the further interpret (Holt etal.,2016). However, two these studiesalso to inform between ontrade-offs farming options analysis potential ofthe approaches ofES-based decision making. Thisechoes outcome the ofan transparency communication and to support put into context provide and means to improve ininterpretingelements relevance the ofrisks (Deacon etal.,2015). two The studiesbring useful carbon and landscape sequestrationas habitat, citrus orchards interms ofbenefits to ESssuch different optionsofrisk inSpanish management ,University ofGothenburg Society, University of for EconomyDepartment and in HumanGeography atthe Sweden, 1997). isaProfessor She Geography (Lund University, EconomicHuman and social scientistwithaPhDin 1963 inAlgutstorp, Sweden) isa Marie Stenseke (born 22August

DAY 2 • 19 September 19 Advancing risk science assessment -Environment from a holistic and contextual and aholistic perspective. from however, alsorecognised thatNCPcan beseen contribution to identity socialcohesion. and Itis, material nutrient provision, butalsoanon-material for example, that food onlyrecognised isnot asa relations between nature. peopleand Itmeans, stressesand ofsocio-cultural importance the perceptionthe experiences and by peopleofNCP, facton the cultural thatthe context influences NCP. classification The places amajoremphasis groups: regulating, material non-material and classification three distinguishes partly overlapping now appliedinIPBES NCP The assessments. contributions to people(NCP) classification (MA) ecosystem to nature’s the framework service MillenniumEcosystem the Assessment from (Diaz etal.,2018). NCPisaconceptual evolution contributions include, for example, food provision natureliving to people’s quality oflife. Beneficial contributions,the bothpositive negative, and of nature agoodquality and oflife (NCP). NCPare all givenelement, thatthey are conduit the between nature’s contributions to people is identified at a key (Diazetal., 2015), inwhich conceptual framework IPBES’s IPBES approach to values from departs has beendeveloped appliedinIPBES. and approach to pluralistic valuation assessments and comparability ofvaluation results, abridging moral responsibility towards nature. To facilitating identity, socialcohesion, socialresponsibility and to relational values, reflecting ofcultural elements environment. Importantly, IPBES alsopays attention the valuesinstrumental ofwhatpeopleobtainfrom that decisionmaking relies to agreat extent on for decisionmaking, IPBES alsoacknowledges values are of‘nature’ recognised asimportant nature relations by held intrinsic people.Whilethe embracing diversity the ofvalues onhuman- from practices aiming at sustainable futures would benefit (Pasucal etal.,2017), recognising thattransformative 2018), developed apluralistic approach to values planet’sthe biodiversity (Stenseke Larigauderie, and knowledge other and holders state thatassessthe of awiderange ofdisciplines scholarsIn IPBES, from of values to need bepromoted indecisionmaking. (IPBES)Services acknowledges thatdifferent types Policy Platform onBiodiversity Ecosystem and yardstick. same the Intergovernmental The Science- institutional contexts are and hard to compare on of life are associated withdifferent cultural and nature itscontributions and to people’s goodquality critical to acknowledge diversity thatthe ofvalues of different often and conflicting ways. It is,therefore, are often perceived valued and by peopleinstarkly Nature itscontributions and to agoodquality oflife Biodiversity Ecosystem and (IPBES). Services Intergovernmental Science-Policy Platform on expert panel ofthe multidisciplinary commissions. At present ofthe co-chair isthe she knowledge communication through various special projects programmes, and with engage and large international numberofnationaland research stakeholders. other and hasbeeninvolved She ina often incollaboration withgovernmental bodies EFSA JOURNAL |SUPPLEMENT Mònica García Alonso ofregulatedassessments stressors fit-for-purpose environmental risk problemUsing formulation to construct Key words: biodiversity, pluralistic valuation, relational values 31(Suppl 1),S10–S14. European Journal ofSocialScience Research, ecosystem (IPBES). services Innovation: The science-policy platform onbiodiversity and workhumanities inthe Intergovernmental ofthe challenges and importance ofsocialsciences and Stenseke role, The 2018. Larigauderie Mand A, Environmental Sustainability, 7–16. 26, to IPBES people:the approach. Current Opinionin Stenseke M,etal.2017. Valuing nature’s contributions Pascual U, Balvanera P, Pataki RothE, DiazS, G, contributions to people.Science, 359(6373), 270–272. Watson RT, Assessing nature’s etal.2018. MolnárZ, Pascual U,Díaz S, Stenseke B, M,Martin-Lopez Sustainability, 1–16. 14, people.Currentand OpinioninEnvironmental —connecting nature conceptual framework etal.2015. IPBES The M, Ash N,Larigauderie A, Carabias Demissew Lonsdale J, S, JolyC, S., Díaz, References over years, the triggers and criteria and for the hasbeenestablished methods set ofstudiesand forIndeed, products, ofthese some averyspecific they typically fall different under legal frameworks. of each type ofproduct canbe very different as datarequirements usedand methods for ERA the ofwhichsome However, are assessedby EFSA. the pharmaceuticals, organisms, modified genetically of products/stressors, such aspesticides,chemicals, EU.in the ERAs These are conducted for avariety making market onthe introduction ofnew products to risk the analyses performed to facilitate decision (ERA)areassessments akey tool thatcontributes Pre-market/prospective environmental risk regulators developers and around world. the providessolutions and training onrisk to assessment research atdeveloping aimed activities GMcrop 7 years ago. private now She supports public and Syngenta for 19years own setupher and consultancy University the ofReading. worked She from for University ofBarcelona aPhDinneurobiology and the degree physiology oninsect ecology and from speciality inzoology entomology. and PlusaMasters the Universitythe ofBarcelona, with hasadegreeShe inbiologyfrom affairs for more than20 years. cropsmodified and regulatory risk ofgenetically assessment has beenworking area inthe of director atEstel Consult Ltd. She consultantindependent and Dr MònicaGarcía-Alonso isan ,Estel Consult

DAY 2 • 19 September 20 Advancing risk science assessment -Environment Jörg Romeis pesticides: effects onnon-target arthropods RNAi-based plantsand modified genetically risk RNAi-based ofinsecticidal assessment Problem formulation for environmental the Key words: environmental riskproblem assessment, formulation crops. Environmental Biosafety Research, 5,119–125. for environmental risk assessments ofgeneticallymodified Problem 2006. Raybould A, formulation andhypothesis testing approach. In:Collection of Biosafety Reviews, pp. 6, 10–65. assessment for geneticallymodifiedcrops: apractitioner’s Gray Problem 2012. AJ, formulation inenvironmental risk 72–101. 8, fit-for-purpose risk assessments. ofBiosafetyCollection Reviews, GMcrops: usingproblem formulationderived to from ensure Garcia-Alonso M,2013. Safety Assessment offood andfeed Environment, 259, 19–27. for geneticallymodifiedmaize. Agriculture, Ecosystems and Environmental risk assessmentandmanagementimplications Teosinte andmaize xteosinte hybrid plantsinEurope- Devos Y, 2018. Hokanson KandRaybould Ortiz-García S, A, References tool to perform fit-for-purpose ERAs. general concepts problem behind formulation asa transparentlogical and way. Thistalkwillexplore the of ERAs for thiswide range of products inascientific, et al.,2018). Thisapproach facilitates performance the Raybould, 2006; Gray, 2012; Garcia-Alonso, 2013; Devos around world the isnow and widelyused(e.g. support hasgained case basis. methodology The are assessments the and conducted onacase-by- reason thatGMOproducts being canbeverydiverse organisms modified genetically main (GMOs),the EFSA hasproposed amore explicit useinERAs for chemicaland risk More assessments. recently, has beenusedimplicitlyfor many years inpesticide formulation’.is ‘problem that Thisisamethodology purpose ERAs. optionthathasbeenidentified One tonecessary find ways inwhich to perform fit-for- tools developed for traditional products, soitmay be challenges indirectly risk the applying assessment ERAs willhave to beperformed there and may be biotechnology products. For products, ofthese some control to and agents synthetic and nanoparticles toinsecticides, genetically modified fish, to biological pesticides, plantsand modified to systemic mosquitoes, to RNAinterference-based genetically drive-modified gene application, ranging from a range ofnew products moving to commercial However,advances scientific aremoving fast with availablebeen made to approaches. these support more and has beengained scientificdatahave acceptability ofrisk have asmore beenset, familiarity EFSA JOURNAL |SUPPLEMENT ,Agroscope University ofBern anadjunct and isalecturer he addition, atthe Federal Office for Agriculture. In research, isaffiliated and to the excellence for agricultural Agroscope Swiss isthe centre of Agroscope inZurich, Switzerland. Biosafety Research Group at Dr Jörg heads Romeis the products (PPP) may have onvalued non-target potential thatGMplantsorplantprotection impacts So, environmental risk (ERA)to assessment assessthe cultural for services speciesofconservation concern. such services asnutrient cycling,supporting and as biologicalcontrol ofherbivores pollination, and This includes, regulating inparticular, such services contributeand to ecosystem important services. biodiversity ofthe part inagricultural landscapes to valued non-target form species.Arthropods amajor in pestcontrol isthatthis could causeadverse effects mainconcerns ofthe One related to useofdsRNA the infoliarthem sprays. plants, microorganisms, orbaits orby applying by providing (GM) modified dsRNAingenetically effects in pest control may, for example, beachieved dsRNAisingested)when ismore limited. RNAi or environmentaldietary RNAi (i.e. an RNAi response tospecies belonging various orders, of impact the anumberofarthropod has beenreported from very targeted pestcontrol. RNAi Whilefunctional to have avery narrow ofactivity, spectrum allowing dsRNAcanbedesigned effect issequence specific, bysilencing anenzyme complex. RNAi Becausethe sequence leading homology to itscleavage so and toRNA (dsRNA)thatbinds RNAwith messenger involves double-stranded smallRNAs, derived from target pests.RNAiinarthropods inarthropod genes for pestcontrol arthropod through of silencing the powerful technology that offers new opportunities RNA interference (RNAi)isanemerging and publications. to GMplantshasresulted peer-reviewed in130+ his practical research conceptual and work related formulating operational protection goals. Intotal, ofpestcontrolassessment technologies in and formulation to environmental guidethe risk hasexperienceDr Romeis useofproblem inthe species. to develop criteria for ofsurrogate selection the test for laboratory studieswithnon-target organisms, and potential non-target effects, to propose designcriteria in developing anapproach for evaluation the of organised ledseveral and international expertpanels protocols for non-target Hehas risk assessment. actively involved indeveloping testing and guidelines toIn addition research, primary hasbeen DrRomeis interference (RNAi). non-target effects ofGMplantsthatare based onRNA recently, performance the alsoisstudying he and herbivores predators their and parasitoids. and More GM plants,such asBtmaize cotton, and onarthropod research hasfocused effects onthe ofinsect-resistant execution ofnon-target laboratory studies.His crops, designand withspecificemphasisonthe riskin the (GM) modified ofgenetically assessment interactions. Hehasmore than17years ofexperience focus onbiologicalpestcontrol multitrophic and was trained asanappliedentomologist witha aPhDinbiologyand anMScand holds Dr Romeis AcademyChinese ofAgricultural Sciences inBeijing. professor Institute atthe ofPlantProtection ofthe

DAY 2 • 19 September 21 Advancing risk science assessment -Environment Alessio Ippolito formulation a retrospective analysis problem ofthe forof neonicotinoid insecticides bees: Environmental risk assessment PPP willbeelucidated. differencesand between RNAi-based GMplantsand proportionate tiered and similarities the and manner on how hypotheses these canbetested ina identified. Furthermore, suggestionswillbepresented presented testable and risk hypotheses willbe that may harm selected protection goals willbe exposures. Inthispresentation, potential pathways those potentialthe adverse effects thatresult from with respect to relevant the exposure scenarios and GMplantsorPPPs,insecticidal differences may exist protection the and goals besimilarto should other regulationspecies. Whilethe (problem context) dsRNA could harm valued non-target arthropod applicationofPPPsGM plantsorthe containing pathways onhow cultivation the ofdsRNA-producing problemset the context to and develop plausible problem formulationEarly isusedto ERA, inthe placement market. inthe (NTAs)arthropods islegallyrequired before their pathwaysthe definitionof identification, the hazard the all appropriate exposure and steps, from formulation was considered by taking into account such guidance general the documents, problem addressing risks 2013). Within to bees(EFSA, by EFSA area inthe one ofpesticideERAisthe latest ofthe One guidance published documents Committee, 2016). (SPGs) (EFSA PPR Panel, 2010; EFSA Scientific aimofachievingwith the specificprotection goals risk schemes, assessment harmonised at EUlevel, roleThe guidance ofthese is to documents provide environmental risk (ERA)ofpesticides. assessment producing guidance up-to-date for documents the Safety Authority (EFSA) hasbeenresponsible for Since itsfoundation European the in2002, Food University ofMilano-Bicocca. the sciences aPhDinecotoxicology and from aMaster’sAlessio holds degree inenvironmental Joint Research Centre EUCommission. ofthe for Pesticides Health and RiskPrevention, atthe and Environmental Research, International atthe Centre of Milano-Bicocca, Helmholtz atthe Centre for Environmental Protection Agency, University atthe workedhe Lombardy atthe Regional EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority assessment. Before joining EFSA, Beforeassessment. EFSA, joining new for methods risk the substances ofdeveloping and care peerreview ofthe ofactive ofpesticides,takingassessment deals environmental withthe risk EFSA’s Pesticides where Unit, he worked asscientificofficer at AlessioIppolitoSince 2014, has revision oftheGuidance Documents onAquatic andTerrestrial inrelationassessment ofpesticides,inparticular to the of specificprotection goaloptions for environmental risk their Residues),2010. ScientificOpiniononthedevelopment EFSA PPR Panel (EFSA Panel onPlantProtection Products and efsa.2018.5179 granules. EFSA Journal 2018;16(2):5179, 59pp. doi: 10.2903/j. thiamethoxam considering theusesasseedtreatments and the pesticiderisk assessmentfor beesfor theactive substance EFSA (European Food Safety Authority), Peer review 2018c. of efsa.2018.5177 granules. EFSA Journal 2018;16(2):5177, 86pp. doi:10.2903/j. clothianidin considering theusesasseed treatments and the pesticiderisk assessmentfor beesfor theactive substance EFSA (European Food Safety Authority), 2018b. Peer review of efsa.2018.5178 granules. EFSA Journal 2018;16(2):5178, 113pp. doi:10.2903/j. imidacloprid considering theusesasseedtreatments and the pesticiderisk assessmentfor beesfor theactive substance EFSA (European Food Safety Authority), 2018a. Peer review of 2013;11(7):3295, 268 pp. doi:10.2903/j.efsa.2013.3295 mellifera, Bombusspp. bees).EFSA Journal andsolitary 2013; risk assessmentofplantprotection products on bees (Apis EFSA (European Food Safety Authority), 2013. Guidance onthe References from the scientific the experience gained over the from years. risk procedure assessment inadvance, benefiting improvements have informulating beenmade the guidance confirms document thattremendous schemes inplace before introducing EFSA the brief comparison risk withthe assessment fromrevision. further A which may benefit problem formulation, aspects some highlighting representsdocument agoodexample ofERA Overall, itwillbeshown guidance thatthe were fullyconsidered not assessment. inthe be usedto possibility discussthe thatrelevant risks risk conclusions assessment onneonicotinoids, will literature search, which served asinputfor bee the have beenconsidered. results The systematic ofthe different levels ofrelevance for addressing SPGs the latest conclusions, inwhich multiple with endpoints weightof the ofevidence exercise included inthe two results issueswillbediscussedinlightofthe a retrospective Particularly, assessment. first the Therefore beaddressed should aspects these in finallythe and failure to identify relevant risks. beeasily (orthatcannot endpoints measured), lack ofclearly goals, defined useofambiguous the by aninappropriate problem formulation are the ERA(USEPA,the mainissuescaused 1998),the analyses role ofthe ofproblem formulation within On ageneral level, according to first ofthe one 2018a, 2018b, 2018c).(EFSA, imidacloprid, clothianidin, thiamethoxam and focus recently onthe conclusions published on experience withaparticular inbeerisk assessment, latest the using guidanceset outinthe document, problem ofthe assessment formulation asitwas substances. Thiscontribution offers aretrospective bees associated usesofneonicotinoid withthe for particularly risks the assessing by to EFSA, guidance hasbeenalready document used Despite noted being not yet EUlevel, atthe this comprisingmethodology different tiers. SPGs, to risk the hypothesis assessment the and

DAY 2 • 19 September 22 Advancing risk science assessment -Environment Claus Svendsen of nanomaterials environmentalin the risk assessment Current scientificdevelopments Key words: bees,neonicotinoids, pesticide,problem formulation EPA/630/R-95–002F. nrEPA/630/R-95–002F. Report US EPA,Guidelinesfor 1998. ecological risk assessment, Journal 2016;14(6): e04499, 50pp. doi:10.2903/j.efsa.2016.4499 inrelation toEFSA, biodiversity andecosystem EFSA services. protection goalsoptions for environmental risk assessmentat EFSA Scientific Committee, Guidance 2016. to develop specific Journal 55 2010; pp. 8(10):1821, doi:10.2903/j.efsa.2010.1821 Ecotoxicology (SANCO/3268/2001 and SANCO/10329/2002). EFSA from massflow not takemodels thatdo based the from NM forms’ peritoneal withthe exudate cells (PECs) laboratory test ‘short withpristine (PNECs) from simply comparing neuroendocrine pulmonary cells efficient and bedone cannot risk assessment by itisequallyclearThen thatadequate, realistic products life-cyclenano-enabled isimpossible. incorporation; disposalphases) ofa useand production; (particle allstages be released from multiple forms inwhich nanomaterials the may detailed physical/chemical characterisation ofthe represents. Whileitisclear thatdealing with environmental risk released their forms potentially maymedia provide not much relevance inthe instandard particles’ –asmade cleanof ‘pristine toxicities ofnanomaterials through testing the recentthe years ithasbecome clear thatranking include regulation. innano aspects these Over risks,and to facilitate safe product to designand potential environmental humanexposure and of nanomaterials, to allow early of assessment distribution, concentration form and (speciation) prediction inthe is needed ofenvironmental approaches may beadequate. not Progress risk and endpoints (ERA)methods, assessment that current chemical based environmental potentialand effects have ledto concern the resultingtheir uniqueenvironmental behaviour ofnanomaterials specificproperties The (NM)and with potential commercial and functional value. nanometer scaleproduces novel distinct, properties engineering size the shapeofmaterials and atthe basicThe foundation ofnanotechnology isthat (UK). NERC (UK),EFSA Defra and FP4–H2020, from majorfunding withother from biomarkers, chemical mixtures materials nano and leader inmany projects EU-funded orpartner on book chapters, coordinated and orbeenaWP EFSA JOURNAL |SUPPLEMENT ,Centre for Ecology &Hydrology co-authored over 100papers and Group. Hehasauthored or Ecotoxicology Risk Chemical and where leads he their Hydrology (UK)inWallingford, NERC Centre for Ecology and environmental research atthe applied and fundamental Claus Svendsen works on Rosalind LeggattRosalind salmon risk ofGMgrowth-enhanced assessment coho Problem formulation for environmental the Key words: ageing,nano, non-standard tests, transformations the potentialthe exposure environment ofthe to the Environmental risk isconsidered of afunction fish to provide scienceadvice for regulatory decisions. engineered genetically (ERA)ofnotified assessment Oceans Canadaconducts anenvironmental (DFO) risk environment orindirectly humanhealth. Fisheries and determine they whether are capable ofharming the assessedbeforeand ormanufacture import to organism products ofbiotechnology to benotified approach to regulation by requiring allnew living biotechnology provisions ofCEPA take apreventative The Regulations (Organisms) [NSNR(O)]. Protection (CEPA) Act New Substances Notification regulated Canadian the under Environmental In Canada, engineered genetically organisms are Protection Act. Canada Canadian the under Environmental commercial engineered useofgenetically finfishin indirect humanhealth risk for assessments alsocontributesRosalind to environmental and expression, health, ecology behaviour and offinfish. triploidy and domestication, onphysiology, gene influence engineering ofgenetic (e.g. transgenesis), trade. Thiswork hasincluded examining the applications related to agricultural practices. fate, transformation allfocused and orageing on possible, each addressing adifferent of element aim to getasrelevant nanomaterial exposures as recent non-standard experiments studiesthat and highlighted through presentation ofaseries of relevant environments. for need The thiswillbe patterns ofrelease relevant ENMsinexposure aim to behaviour and understand functional the cell model endothelial membranes to (ENMs)and physical/chemical the from ofpristine properties means. Therefore, we propose to move focus away resourceand intensive beyond available most concentrationsand istechnically challenging soinenvironmentally doing and relevant media Again tracking such transformations indetail developedproperties insuch transformations. materials new onthe depend physical/chemical fatethe processes behaviour and released ofthe release to environment the into account. For one transformations ofnanomaterials bothpre post and and the ornamental the and aquarium foraquaculture useinfood-fish infinfish modification genetic environmental consequences of examine potential the focus research ofher isto Oceansand Canada The (DFO). Scienceand Advisor for Fisheries LeggattRosalind isaBiologist ,Fisheries andOceans Canada

DAY 2 • 19 September 23 Advancing risk science assessment -Environment Canada Gazette PartII,Vol. 139, No. 19, SOR/2005-248. New Substances NotificationRegulations(Organisms), 2005. 685-700. accelerated geneticallyengineered fishes.BioScience, 65: ecological and evolutionary consequences ofgrowth- Devlin RH,Sundström LF,2015. Assessing andLeggatt RA, Ottawa, ON.p. 26. Canadian Secretariat Science Advisory 2013/023, Science Report, health risk assessmentof AquAdvantage® salmon.DFO DFO, ofthe environmental 2013. Summary andindirect human References tosalmon minimiseenvironmental risk. ofcontainment importance ofGHtransgenic coho be ahazard to environment, the demonstrate the lackand ofevidence organism the indicating willnot hazard to ecosystem components, incomplete sterility Highuncertaintysalmon. levels inestimating of hypothetical commercial useofGHtransgenic coho an estimated low environmental risk ranking for exposure rank highhazard and rank results in (see Devlin etal.,2015). estimated The negligible environmental conditions, strain background, etc. age ofescapedtransgenic wild-type fish,the fish, conditions, onrearing history oftransgenic and were laboratory runinthe semi-natural orunder varied greatly experiments onwhether depending of hazards oftransgenic coho to salmon wildfish predict long-term consequences. Identifiedlevel predation hybridisation), and withdifficult-to- (e.g. through competition for food ormates, hazard through interactions withnative organisms triploidy, would and environmental highest posethe behaviour physiology, and are 100%sterilised not by transgenic coho have salmon strongly affected (DFO 2013). Research dataindicate thatGH exposure to organism, the withlow uncertainty results ranking innegligible for environmental Canadian environments, anexpected lack ofentry inlimitedand, circumstances, reproduce in organism would beexpected to survive,disperse, production ofall-female triploid Whilethe salmon. estimated land-based assuming commercial Environmental exposure was GHsalmon ofthe developedsalmon for research. of ERAprocesses for ofGHtransgenic aline coho Canada. As atest case,we implementation discussthe engineered fishapproved for human consumption in for fast growth iscurrently onlygenetically the containingsalmon agrowth hormone (GH)transgene in regulatory decisionmaking AnAtlantic isneeded. informsand applicationofprecaution the whether (risk =exposure ×hazard). Uncertainty isestimated for organism the to beahazard to environment the organism modified genetically potential the and EFSA JOURNAL |SUPPLEMENT Andrew Roberts mosquitoes risk drive-modified ofgene assessment Problem formulation for environmental the inform risk the process, assessment especially process such as problem formulation to better necessity)the anorganised ofapplying scoping ofmysome own conclusions utility about the (and consultations, aswell sources, asother Iwillshare facilitating problem formulation exercises atthese experience in place in2016–2018. Drawing from organised aseries ofregional consultations taking Development (NEPAD) Partnership for African drive technologies to control malaria, New the considerationthe ofpotential future useofgene- thatwillfacilitateTo begindiscussionsinAfrica to feasibility so into and publicconsciousness. the biologyhavemolecular brought thisidea closer scientists for butrecent decades, advances in by vector-borne diseases hasbeenofinterest to address intractable public health problems caused potentialThe to usegene-drive mechanisms to signal transduction nematode model inthe elegans. C. Rutgers University where worked he Biology from on Andrew received hisPhDinCell Developmental and ILSIuntil joining RF. International Affairs branch where remained he on Biosafety, returned he to BRSto serveinthe for USDA’s related efforts to Protocol Cartagena the Foreignthe Agricultural lead asthe serving Service ayearspending New inthe Technologies office of After engineeredgenetically plantsatUSDA. group (BRS),the Services responsible for regulating Office ofScience ofBiotechnology Regulatory at USDA RiskPolicy asan AAAS Fellow inthe agricultural biotechnology. Hebeganhiscareer capacities, allrelated to regulation the of ofAgricultureDepartment inseveral different AndrewBefore worked CERA, joining US atthe Assessment ofFood Feed and (CSAFF). director ofCERAaswell Centre asthe for Safety of2015 the became he InJanuary South Africa. workbuilding inBrazil, Japan, India, Chile,and as well asproviding technical for capacity support Pakistan,Regulation, inBangladesh, Vietnam and Partnership for Biosafety RiskAssessment and Program (SABP) World the and Bankfunded SouthAsia Biosafety USAID-funded the under coordinator for CERA’s capacity projects building Foundation (Wolt etal.,2009). Hehasserved asthe risk by published assessment Research the problem formulation approach to environmental ,ILSI Research Foundation capacity related building, to the materials for useintraining and included developing tools and (CERA), where hisfirst tasks Environmental RiskAssessment Director Centre ofthe for December 2009 Deputy asthe ILSI Research Foundation in Dr Andrew the joined Roberts

DAY 2 • 19 September 24 Advancing risk science assessment -Environment Richard Shaw versus fungi and insects agents: weeds risk ofweed assessment biologicalcontrol Problem formulation for environmental the Key words: mosquito, problem formulation, risk assessment American Journal ofTropical MedicineandHygiene, 530–533. 96, ‘Problem Formulation for theUseofGeneDrive inMosquitoes. 2017. theWorkshop andJames S, M, SinghJA, Results from DeAndrade PP, A, Roberts Okumu F, QuemadaH,Savadogo References altered ecosystemfrom interactions. water quality, potential the and for harm resulting health, potential the for larvae to aquatic influence capacity humanoranimal thatmightimpact includeThese potential alterations to vectorial future risk for assessments gene-drive mosquitoes. thatcanprovide endpoints assessment guidance to technology. Iwillalsoreview commonly identified as itrelates to new technologies ornew usesof International a similarclassical weed biocontrol butwith project, which isequallywidespread, iscurrently to subject In contrast, invasive the Himalayan balsam plant, area released when into environment. the likely to beinjurious to risk plantsinthe assessment applied asamycoherbicide. However, are bothagents latterthe isamicroorganism thatisintended to be permanentthe suppression target ofthe weed, while that isintended to bereleased onafew occasions for perspective,assessment former the isananimal sucking psyllid aleafspot and From fungus. arisk plant inJapan have beenwhittled down to asap 2, than 200 natural found enemies attacking the Followingagents. 15years almost ofresearch, more use ofnatural appliedasbiologicalcontrol enemies techniques. However, itmay besusceptible to the usesphysicalmanagement chemical and beyondis certainly eradication widespread and native range inJapan early inthe century. 19th It its America. Thisnoxious speciesarrived from economies across Europe northern North and invasive speciesthatharms ecosystems and Japanese knotweed isanotorious non-native which since hasbeenstudying he last century! the weeds UK,including inthe Japanese knotweed, that could have riparian and onaquatic animpact overseeing ateam ofresearchers working onweeds in more than20 countries. Heiscurrently applied entomologist having carried outfieldwork EFSA JOURNAL |SUPPLEMENT ,Centre for Agriculture andBiosciences years isanexperienced and of mainlyweeds for CABI for 24 worked biologicalcontrol onthe Centre inEgham. Dick has Country Director for CABI’s UK Americasthe aswell asbeing forspecies activities Europe and Coordinator for CABI’s invasive Dick Shaw Regional isthe Christopher J. Topping current challenges statusand population-levelLandscape-scale ERA: southern Europe iscurrently and implementing eastern simulationsinnorthern, landscape and is involved indeveloping pollinator and models been involved inEFSA working groups since 2009. He Residues (PPR) Panel, ofMUST-B, amember has and vice chair EFSA ofthe PlantProtection Products and of agricultural chemicals, crops, practices. and Heis environmental and management risk assessment ecological systems for useofmodels the and wildlife (ABMs), leading towards simulationofsocial- of complex multifaceted agent-based models years. fieldisdevelopment Hisprimary and testing nothing is not alow isnot nothing risk option. biological systems. For invasive species,doing astheremanagement, isalways asmallrisk in to utilisethistried-and-tested approach to weed riskalongside itwould impossible then bevirtually not is Ifbenefit alongside benefit consideredrisk. release issueofconsidering raise and important the relevantnot to anintentional classical biocontrol questions inastandard pestrisk are assessment Itwillalsoshowof agents. halfofthe thatalmost twothe different strategies two and different taxa convenient very current and casestudiesthatshow control knotweed the using balsam and projects as practice ofclassical inundative and biological This presentation willcover principles the and as efficacy usersafety and aremore important. while mycoherbicides willbeplaced market, onthe vulnerability the and attacked plantpart ofthe programme is largely determined by specificityhost for ofanagent selection The aclassical biocontrol are to added environmental the risk consideration. organism risk then to operator the consumers and For aninundative normally and formulated attack, orindirect such asapparent competition. organism such canbedirect, and asnon-target for environment the ofarelease ofanexotic biocontrol are agents focused consequences onthe similar. Ingeneral, risk for assessments classical des Plantes pest risk (EPPO) form assessment is Européenne etMéditerranéenne pourlaProtection risk process assessment based Organisation onthe are regulated inavery different way. Thankfully, the taxabecause oftheir differing indeed and size, they for psyllid the thisand are identical,but almost ecological principles, strategy safety and testing intended not a fungus for usethrough anozzle. The and riskand for assessment over 20 affecting wildlife management practices agricultural and policy ofprimarilyimpacts agricultural environmentalmodelling has beenworking with Aarhus University, He Denmark. MSO inEcological at Modelling Christopher Topping isProfessor ,Aarhus University

DAY 2 • 19 September 25 Advancing risk science assessment -Environment Key words: context-dependency, ALMaSS, systems model 1477–1488. Brown Hare model.Science oftheTotal Environment, 541, ofendocrineimpacts disruptionusingtheALMaSSEuropean management alter theoutcome Evaluating ofapesticideERA: Topping Dalby C, LandSkov F, Landscape structure 2016. and EFSA Journal 2016;14(2):4313,risk assessmentsatEFSA. 4385 pp. EFSA Scientific Committee, Recovery 2016. inenvironmental References in later developmental steps. expand to systems, other including systems aquatic mammals, birds aimisto butthe insects and initiated for arestricted setofspecies terrestrial (Topping, Dalby etal.2016). Thisprocess hasbeen providedmethods by ALMaSSframework the capture landscape simulationand landscape to generate regulatory scenarios, existing and will useexisting EUdatasetse.g. by held JRC, environmental fate simulation Landscape models. include current ofnon-target models animalsand State ®ional) context. blocks building These systems thatincludes model relevant local(Member currently available to them adapt and provide a 2016). Thisendeavour blocks building willusethose systems approach (EFSA Scientific Committee ERAfor a pesticidesusing of landscape-scale Currently EFSA isworking towards implementation exist are and adapted being for use. of mammals,birds terrestrial and already arthropods stressors other pesticides and models onbees.Other structure dynamicsto and predict of impacts based honey thatwillutiliselandscape beemodel already. EFSA isdeveloping ApisRAM,anindividual- ERAhave landscape-scale for beentaken supporting Several steps towards development suitable ofmodels on choice ofrepresentative scenarios. speciesand specific protection goals decisions atthisscale,and conceptual issuesrelate primarily to definitionof of datarequired The to activities. these support testingand volume the obtaining and ofmodels structure aswell function, and development asthe to for need the accurate simulationoflandscape conceptual.and technical The challenges related aremitigation options.Challenges bothtechnical abletoof being tools same usethe to evaluate space knock-on Thishasthe time. and benefit between stressors animalpopulationsin and themselvesanimals find in,and interactionsto the able to predict related risk, to context the the are primarilyopportunities related to better being to grasp challenges and to overcome. The there areparadigm bothopportunities shiftinERA, Naturally, dealing when to withwhatamounts a EFSA ofthe strategyalso part for 2020. incorporation risk is assessment oflandscape-scale acknowledged inrecent EFSA scientificopinions.The populations ofnon-target organisms, ashasbeen determining outcome the on assessment ofthe have function, and role to averyimportant play in beignored. cannot aspects itsstructure Landscape, but itisbecoming increasing clear that ecological Current guidance inERAhasitsfocus on toxicology, EFSAApisRAM, the honey beecolony model. EFSA JOURNAL |SUPPLEMENT Wendy Craig Engineering &Biotechnology https://www.linkedin.com/in/wendy-craig-3209785a/ GMO biosafety. For details,see further 2005. regularly She reviews and authors articles in before ICGEB the joining Biosafety Group inJanuary post-doctorate studiesinvarious world ofthe parts conducting aseries ofplantbiotechnology-based manipulation ofoilseedrape. Thisledto her approachesin 1996studying for genetic the Craig PhDatNottingham her gained University, UK experts operating insimilarorassociated arenas. Dr synergies withinternational organisations and rely onstrengthening collaborations creating and levels. individual institutional and activities These dissemination, focusing governmental, onthe needs inGMO identified informationregulation and actively projects managing targeting locally States (primarily developing countries). is She ,International Centre for Genetic enhancement Member intheir involved inbiosafety capacity Group, which isprincipally Leader ICGEB’s ofthe Biosafety Craig iscurrently Group the (ICGEB), Trieste, Italy. DrWendy Engineering Biotechnology and International Centre for Genetic Group Leader –Biosafety,

DAY 2 • 19 September 26 Advancing risk science assessment -HumanHealth Human health Advancing riskassessmentscience this transition willbediscussed. shift may entail.New tools thatmay facilitate accounting for challenges the thataparadigm characterisation) willbeaddressed holistically, characterisation, exposure risk and assessment traditional risk paradigm assessment (hazard ofthe usefulness The assessment. for needs and humanhealth risk advances, unresolved challenges, This sessionwillhighlightrelevant reduction ofanimaltesting. health risk aswell assessments asthe promising for improvement the ofhuman developments These pathogenesis. the are toalone provision the ofinformation on empirical observations transition from epidemiological research isfacing a testingnon-animal Moreover, models. responses. tools Mostofthese willbe more accurate predictions ofbiological adverse effects level, molecular atthe and that enableabetter understanding of Newassessments. tools are emerging usedtoand advance further risk epidemiologycouldand beintegrated advances intoxicology, exposure science how latest the scientificand technological considerations recommendations and on thatprovides areport published Engineering, recently Medicine and NationalAcademiesThe ofSciences, EFSA JOURNAL |SUPPLEMENT Guilhem DeSezeGuilhem CHAIRS Maurice Whelan Bioengineering University atthe ofLiverpool (UK). Professor visiting Brussel (Belgium)and of Chair for alternative Vrije atthe methods Universiteit includingappointments 2017–2018 the Francqui (EPAA). anumberof external Heholds for Alternative Approaches to AnimalTesting Steering Committee European ofthe Partnership Outcome Pathways, ofthe isamember he and responsible for OECD the programme onAdverse Molecular Screening Toxicogenomics and thatis Group OECD ofthe EU co-chair Advisory on research.applications inbiomedical isthe Whelan regulatory safety ofchemicals assessment for and alternative approaches to animaltesting bothfor development,the validation promotion and of Alternative Priorities Methods. ofhiswork include (former)the European Centre for Validation the of which 20 builds onthe years ofECVAM, ofactivities protection ofanimalsusedfor scientificpurposes, EUDirective under established 2010/63 onthe Animal Testing (EURLECVAM) JRC, ofthe Union Reference Laboratory for Alternatives to Louisiana State University.engineering from for overindustry 10years. aPhDinchemical Heholds chemical inthe and inacademia management Before worked this,Guilhem inhazardous chemicals chemical substances hazardous their and properties. scientificand assessing technical information about for then and Evaluation; bothUnitswere incharge of ,JointResearch Centre Identification and Data Sharing, DataSharing, Identification and first of Unit, for Substance where in2011 ahead became he AgencyChemicals inHelsinki, worked for European the From he Department. 2008, Evaluation ofRegulated Products 2016 ashead Scientific ofthe deSezeGuilhem EFSA joined in He alsoheads European the Centre (JRC),based inIspra, Italy. Commission’s Joint Research Materials European ofthe Consumers Reference and Directorate for Health, Alternative Unitofthe Methods head Safety Chemical ofthe and Professor Maurice is Whelan ,European Food Safety Authority

DAY 2 • 19 September 27 Advancing risk science assessment -HumanHealth Heather Wallace Angelika Tritscher Society of Chemistry Journal.Society ofChemistry Editor-in-Chief ofToxicology Research, aRoyal Toxicologist. hasrecently She beenappointed Toxicologists aEuropean and Registered Heather UKRegister ofthe isamember of is alsoaFellow offour learned other Societies. is Specialty Advisor for Toxicology College. atthe She is aFellow Royal ofthe College ofPathologists and President British ofthe Toxicology Society. Heather Programme Committee. is Immediate She Past to isanadviser (USA) and IUTOX Scientific Programme Committee ofSociety ofToxicology Committee. Scientific ofthe isamember She EUROTOX ischair and Scientific ofthe Programme cancer biology. Heather isPresident-Elect of lectures inpharmacology, drugdiscovery and undergraduate teaching and inBio-Business drug therapy. co-ordinates She post-graduate and related risks asbasis for international, Codex, standards. including ofallfood- assessment the management, heading unittasked the withrisk and assessment ofFoodDepartment Safety Zoonoses, and is she assurance WHO joined and in2003. Inthe private sector incorporate quality safety and experience infood safety worked she first inthe EFSA JOURNAL |SUPPLEMENT ,University ofAberdeen monitoring efficacy ofanticancer biomarkers for and diagnosis useof the delivery and prevention, selective drug are incancer therapeutics and Aberdeen. Herresearch interests Toxicology University atthe of Biochemical Pharmacology and Heather Professor isthe of food safety. With over 25years focused onappliedscience in environmental health she After aresearch carrier in human health risk assessment. experience intoxicology and extensive research applied and registered toxicologist with Dr Angelika Tritscher isa ,World Health Organisation Authority George Kass Anna Federica Castoldi RAPPORTEURS Anna Lanzoni University ofMilan. the veterinary hygiene pathology and from veterinary doctor, medicine hasaPhDin and toxicological Annagraduated pathologist. asa Institute. Stockholm’sbiochemical toxicology Karolinska from Master’s degree intoxicology aPhDin and toxicology. George hasadegree inbiochemistry, a overpublished 100papers abstracts and in professor Karolinska atthe Institute. Hehas Institute ofTechnology inZurich, assistant and in pharmacology toxicology and in2002. University the specialised further ofMilan,and from has aPhDinfood environmental and toxicology Konstanz ataresearch and Institute inPavia. She University ofWashington, University atthe of food neurotoxicants contaminants and atthe research area inthe toxicology molecular ofthe of ,European Food Safety Authority ,European Food Safety Authority researcher Swiss atthe Federal Previously, was he apostdoctoral University ofSurrey (1994–2009). was professor oftoxicology atthe 2009. he Before EFSA, joining Emergingand Risks Unitsince at EFSA’s Scientific Committee scientific officerand toxicologist, George Kass hasbeenasenior carried she EFSA in2008, out Before joining A. on bisphenol EFSA’s extensive scientific work past 9years hascoordinated she Food Contact Materials. Over the where leads she Team the of Food Ingredients Packaging, and scientific officer in EFSA’s Uniton Anna Castoldi isasenior pharmaceutical asa industry worked for 20 years inthe Previously,guidelines. she development ofrisk assessment the ofGMOsand assessment isinvolvedShe risk inthe at EFSA’s GMOUnitsince 2013. scientific officerand toxicologist Anna Lanzoni hasbeenasenior

European Food Safety

DAY 2 • 19 September 28 Advancing risk science assessment -HumanHealth Michael Siegrist risk perception How simpleheuristics influence laypeople’s SPEAKERS Andrea Terron organisms) are perceived as healthier thanproducts modified genetically from palm oil,free from free labels(e.g. from’ Therefore, products with‘free substancescertain product impliesthe ishealthier. healthinessthe offoods absence isthatthe of heuristic thatpeoplemay evaluating applywhen with conventional breeding technology. Another compared risks withthe associated benefits and with thistechnology are perceived differently when why risks, the aswell associated benefits, asthe unnatural also seemsto reason beanimportant nature. Perceiving technology gene from to be if they are causedby humansthanifthey stem negative outcomes are perceived to bemore severe naturally occurring (e.g. Campylobacter). Indeed, hazardthe by ismade humans(e.g. glyphosate) or influence onpeople’s perceptions, butalsowhether consequences ofahazard thathave asignificant studies indicate negative onlythe thatitisnot people’s hazard evaluations. results The ofsuch example, natural synthetic isgoodand isbad, in has focused role onthe ofsimpleheuristics, for laypeople’s risk perception. Recent research relevant quantitative information, strongly influence qualitativeThe characteristics ofahazard, not and decision making. communication, food behaviour environmental and numerous aboutrisk articles perception, risk trust, Editor journal ofthe Appetite. Hehaspublished Editor journal ofthe RiskAnalysis anExecutive and l’Ecole NationaleVétérinaire d’Alfort. experimental toxicological and pathology from veterinary doctor, medicine hasaPhDin and toxicological Andrea pathologist. graduated as EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority ,ETHZürich Siegrist isanAssociate Area University ofZurich. Professor masscommunicationand atthe studied psychology, economics Switzerland. Professor Siegrist ETHZurich,Decisions (IED), Institute for Environmental for Consumer Behaviour atthe Michael Siegrist isafullProfessor pharmaceuticalthe asa industry involvement started in1986 products. Hisprofessional plantprotection and medicinal riskis inthe of assessment Pesticide Andrea’s Unit. expertise toxicologist,and atEFSA’s been aseniorscientificofficer Since Andrea 2012, Terron has Engineering andMedicine Ellen Mantus challenges and opportunities assessment: science 21stcentury toUsing improve risk Although others scientistsand expect that laboratories academic and has accelerated. government, of diverse industry datastreams from have formed to advance generation visions, and the organisations United outsidethe withinand States collaborationsreports, ofvarious and agencies computationaland tools. Since release the ofthose monitoring technologies, techniques analytical of exposure science given advances in,for example, a Strategy, which expanded breadth the depth and Exposure Science 21stCentury: AVision inthe and several years later NationalAcademies inthe report, A visionfor exposure science was articulated chemical exposure.potential adverse effects from in vitro assays computational and tools to assess toxicity testing primarily relies onhigh-throughput computational power to envision afuture inwhich relatedin biologyand increases fieldsand in a Strategy, which advances capitalisedonthe Toxicity Testing 21stCentury: AVision inthe and Engineering released Medicine and areport, In 2007, NationalAcademies the ofSciences, Cornell University NY, inIthaca, from USA. Dr Mantusreceived PhDinorganic her chemistry regulatoryand onawidearray support ofprojects. toxicological provided studiesand risk assessment reviewer served asaprimary she for numerous was aproject withICFConsulting, manager where Before NationalAcademies, the joining DrMantus vehicles associated and charging infrastructure. evaluatedand barriers to deployment ofelectric to federal onrisk-based agencies decision-making, toxicology provided risk and assessment, guidance for modern applying scientificapproaches in various chemical exposures, developed strategies thathaveones health assessedthe implicationsof studydirectorthe onnumerous projects, including best available scientific evidence. perceptions sothatthey fall more withthe inline communication intended to change laypeople’s are perceived. Thisposesachallenge for risk to have onlyalimited onhow impact hazards However, providing information to laypeople seems may result made. decisions being innon-optimal been observed indifferent contexts, they and people’s reliance onsimpleheuristics havefrom suchwithout labels.Biaseddecisionsthatresult ,USNationalAcademies ofSciences, assessment. She hasserved as She assessment. fieldsof in the toxicology and risk with over 20 years ofexperience Engineering, USA Medicine, and National Academies ofSciences, ToxicologyStudies and atthe Boardthe onEnvironmental Director ofRiskAssessment on Dr MantusisaScholar and

DAY 2 • 19 September 29 Advancing risk science assessment -HumanHealth Susanne HougaardSusanne Bennekou for purpose? current –isthe assessment approach fit Holistic approach to humanhealth risk Mantus was studydirector. the Williams, Fred Wright Lauren and Zeise. Ellen Teeguarden, Tiedje, James Paolo Vineis, Michelle Beate Ivan Ritz, Tanguay, Rusyn, Robert Justin Greene, Heather Patisaul, Kristi Pullen Fedinick, Burchard, George Daston, David Dunson,Nigel (chair),Samet MelvinAndersen, Esteban JonArnot, Evaluations. Committee members were Jonathan Incorporating 21stCentury Science into Risk-Based authored Medicine and by Committee the on NationalAcademiesthe ofSciences, Engineering presentation willbebased of onareport *The into risk assessment. challenges for incorporating science 21stcentury and Academies highlightopportunities and report from the recent National casestudies and findings be critical. Thispresentation willbriefly describe key challenges. collaboration Multidisciplinary willalso risk to applicationswillhelp assessment address the that capture various scenarios ofdataavailability for develops, explores, casestudies documents and there isapath forward, aresearch and that agenda large datastreams for However, risk assessment. interpret integrate and diverse, the complex and has evolved far faster thanourability to analyse, challenge thatloomslarge.particular Technology still to beresolved, identifiedone report the Although there are many technical challenges science,century casestudieswere and described. that could benefit by incorporating 21st the ofnewassessment chemicals –were identified site-specific and assessment assessment, applications. Four areas –priority setting, chemical generated today canbeusedinrisk assessment Related Evaluations, examines how databeing the 21stCentury Using Sciencereport, to Improve Risk- to achieve fully, recent the NationalAcademies visionswilltake ofthe implementation decades Environmental Protection Agency nervous systemnervous thyroid the and system. Memberof risk ofpesticidesfor assessment effects their onthe system nervous the thyroid and system. Cumulative groupsassessment ofpesticidesfor effects their on ofcumulativeoutputs onestablishment combined exposure to multiple chemicals. Scientific for humanhealth ecological and risk of assessment harmonisation ofrisk methodologies assessment EFSA JOURNAL |SUPPLEMENT EFSA guidance for document am involved indeveloping: the PPR Currently, 2018. 2010-medio I chemicals. Vice-chair ofEFSA’s REACHbiocides and regulated involved inrisk of assessment regulatory toxicologist also DanishEPA.Division ofthe As a Senior Advisor Pesticide atthe

Danish Danish Thorhallur IHalldorsson strengths deal and limitations withtheir risk how assessment: to take advantage oftheir Use ofepidemiologicalstudiesfor chemical experimental conditions. However, for humans, based onstudiescarried controlled outunder riskChemical ideally should assessment be reviewed international journals. overpublished 90 papers in international peer- nutrition surveys. Since 2007 Thorhallur has formethods use inepidemiologicalstudiesand covers development the assessment ofdietary Environmentaland Epidemiology. Hisresearch also beenfocusedmostly fieldsofNutritional withinthe Public Health hisresearch Sciences (PhD) has (BSc),Chemistry (MSc) AppliedMathematics and Committee (2018–2021). With background in this, among: potential? Thistalkwilldiscussseveral of aspects are flexible enough to takeadvantage full ofthis ourcurrent questioniswhether the EUregulations potentialhas the to improve but risk assessment, based There risk assessment. isconsensus thatthis identification ofapicalendpoints mechanism-to a risk based assessment on risk from assessment: reflections striving onthe for a paradigm shiftin previousThe presentation hasprovided approach to testing assessment. and neurotoxicity assays definitionofatiered and interpretationand ofinvitro developmental OECD project ‘OECD Guidance application onthe steering Memberofthe assessment. team onthe alsoto mixtureassessment, risk support mechanism-based toxicity testing risk and project ‘EU-ToxRisk’, which aimatdriving steering team H2020 inthe member supported EFSA’s Scientific Committee 2018–2021. Involved asa based risk ofchemicals. assessment wanted‘ steps towards transition to amechanism- Finally, ‘most discussthe and talkwillidentify the • • • • recognition risk ofthe outputs? assessment Can we ensure time same atthe mutual Do we make useofexisting most the data? accompanying guidance documents? Do we more need flexibility the and inthese Are standard the requirements fit for purpose? of the EFSAsof the Scientific in Copenhagen isamember and Research, Statens SerumInstitut Health Surveillance and Divisionof senior scientistatthe anexternalalso holds positionas University ofIceland. Thorhallur Science Nutrition and atthe Professor Faculty at the ofFood ,University ofIceland

DAY 2 • 19 September 30 Advancing risk science assessment -HumanHealth Marcel Leist for mechanism-based hazard assessment. New approach (NAM)intoxicology methods areas such asfor chemical contaminants. products such lessconstrained aspesticidesand regulated issuesdrawingthose onexamples from aim ofthispresentation isto address of some formethodology chemical The risk assessment. keystudies isthe advancing for the further toxicological humanobservational studiesand between strengths weaknesses and ofclassical compromises are Abetter needed. understanding compatiblenot complexities with these and for chemical risk isgenerally assessment framework human studiescanbeconflicting. current The lifestyle different factors means thatresults from to chemical exposures interaction and withother highvariability the addition, interm ofsusceptibility that unexposed exist. usuallydonot individuals In occurrence co-exposures ofother fact the and animal studiesare more complicated dueto the confounding), useofhumancompared with general limitationsinbias(including from Apart available for risk assessors. more frequently human observational studiesofsufficientquality access to computerised health datahave made in samplevolume cost; and aswell asimproved inrapidchemistry development, method reduction studies. Recent advancements inanalytical from humanobservational incorporating findings precision inrisk canbeimproved assessment by safety factors, itisincreasingly acknowledged that reduced limitationscanbepartly these by useof observed inhumans.Although thanthose higher to useofdosesthatare humansand usuallyfar fromrelated animals to extrapolating findings limitationsofthatapproachThe are uncertainties by reliance onexperimental studiesinanimals. chemical risk have assessment largely beendriven reasons, procedures for regulatory and framework have traditionally hampered use.For their these new substances limitations methodological and to needed time the generate reliable results for observational studiescanbeusedasanalternative, potentially harmful substances. Although human such experiments beperformed cannot for pharmacological toxicological and characterisation differentiation to neuronal lineages aswell asthe Hisresearch2000–2006. comprises stem-cell Danish pharmaceutical company Lundbeck from A/S as Headofdisease ofDepartment biologyatthe Testing inEurope (CAAT-Europe). Marcel alsoworked EFSA JOURNAL |SUPPLEMENT ,University ofKostanz Centre for Alternatives to Animal foundation), director and ofthe by Doerenkamp-Zbinden the Konstanz (since sponsored 2006, University atthe biomedicine of in vitro toxicology and of been head department ofthe PhD (pharmacology, 1993) has Marcel MSc(toxicology, Leist, 1989), and relevantand adverse outcome pathways (AOP). normal brain development, DNTpathophysiology, by knowledge pathways ofsignalling for necessary NAMdevelopmenton how further may beguided (IATA). assessment and Finally, avisionispresented assembled into anintegrated approach for testing suggestions are onhow made DNTNAMmay be are currently athighreadiness levels. Therefore, scoringThe results suggested thatseveral assays uses (e.g. prioritisation/screening, risk assessment). test readiness of17NAMswithrespect to various quantitative analysis process was assembled on criteria are presented. Onthisbasis a(semi) NAMs.Readiness intended datafrom useofthe test readiness levels are onthe useful,depending of DNTtesting, to show thatdifferent types of background regulatory onthe scientific status and prioritisation testing. for further We give here a information onpotential hazards, to and allow high-throughput NAMapproaches, to obtaininitial DNT testing. So, there for isaneed inexpensive, cost perchemical are overwhelming for invivo number ofchemicals tested, not testing the and exemplify applicationofreadiness the criteria. The neurotoxicity (DNT)testing hasbeenchosen here to NAM would field ofdevelopmental beuseful.The a process criteria and to the define readiness ofthe approach (NAMs)inaregulatory methods context, never beenformally validated. To usesuch new Multiple non-animal-based test have methods relevantand adverse outcome pathways (AOP). normal brain development, DNTpathophysiology, by knowledge pathways ofsignaling for necessary NAMdevelopmenton how further may beguided (IATA). assessment and Finally, avisionispresented assembled into anintegratead approach to testing suggestions are onhow made DNTNAMmay be are currently athighreadiness levels. Therefore, scoringThe results suggestthatseveral assays uses (e.g. prioritisation/screening, risk assessment). test readiness of17NAMswithrespect to various quantitative analysis process was assembledon criteria are presented. Onthisbasis a(semi) NAMs.Readiness intended datafrom useofthe test readiness levels are onthe useful,depending of DNTtesting, to show thatdifferent types of background regulatory onthe scientificstatus and prioritisation testing. for further We give here a information onpotential hazards, to and allow high-throughput NAMapproaches, to obtaininitial vivo DNTtesting. So, there for isaneed inexpensive, testing cost perchemical are overwhelming for in numbersThe ofchemicals tested, not the and to exemplify applicationofreadiness the criteria. neurotoxicity (DNT)testing hasbeenchosen here NAM would fieldofdevelopmental beuseful.The a process criteria and to the define readiness ofthe approach (NAMs)inaregulatory methods context, never beenformally validated. To usesuch new Multiple non-animal-based test have methods with >200 publications, cited over 15,000 times. neurotoxicity.and Hehascontributed to field the based toxicological tests for developmental toxicity major focus ofhuman-cell- establishment isthe of test systems invitro and disease His models.

DAY 2 • 19 September 31 Advancing risk science assessment -HumanHealth on Food Additives andNutrient Sources Added to Food Marike Kolossa-Gehring Programme HBM4EU Human biomonitoring: European the Joint YounesMaged management of the German ofthe management HumanBiomonitoring Agency isincharge she scientific lead ofthe and ofanumberprofessionalmember societies. various policy scientificand meetings/sessions. a Heis lectures chaired and plenary and moderated and During hiscareer, gave he numerous presentations editor/co-editor ofsixbooks special journal and issues. 40bookchaptersand review and is and articles, Dr Younes around haspublished 150original papers dell’Approccio Centrato SullaPersona (IACP) inRome. Environmental Health Istituto Studiesofthe Bangkok, aProfessor and Thailand, ofPublicHealth/ Professor Chulabhorn atthe Research Institute Gordon University, Aberdeen, Scotland, aVisiting Occupational Health Sustainability, and Robert- a Visiting Professor ofEnvironmental and University ofLübeck, Germany until2015. Hehasbeen Toxicology Biochemical and Pharmacology, Professor hasbeenanAdjunct he addition, of MemberofEFSA’sand Scientific Committee. In European(ANS) ofthe Food Safety Agency (EFSA) Food Additives Nutrient and Panel Supplements Health. others, Among iscurrently he Chairofthe InternationalIndependent Global Public Expert, asan activities hisscientific maintained Safety Zoonoses and atWHO in2013, has he zoonoses.and Since hisretirement asDirector, Food governance external and relations, food and safety environmental health, environmental conventions, programmes, including chemical safety, directed and managed various technical policy and Environment Programme). At WHO UNEP, and he two-year secondment to United the Nations World the joined Health Organization (including a Biochemical Pharmacology inGermany, DrYounes a researcher Professor and ofToxicology and EFSA JOURNAL |SUPPLEMENT

European Food Safety Authority’s Panel Following career anacademic as University ofLübeck, Germany. Medical the Pharmacology from Toxicology Biochemical and adegreeand ofDrhabil.in University ofTübingen, Germany, the Physiological from Chemistry and a PhDinBiochemistry YounesMaged anMScand holds Kiel. German Inthe Environment Christian-Albrechts-University the PhDfrom her obtained HBM4EU coordinator. She Environment Agency, Germany. Monitoring’, German Health-related Environmental Head ‘Toxicology, ofSection

German Environment Agency programme grant under agreement no. 733032. Union’s Horizon 2020 research innovation and European the This project hasreceived from funding programmes. EUmonitoring nationaland research and from policy makers. Itbuildsuponexisting knowledge after consultation withEuropean national and policythe priority and needs chemicals identified research The methods. programme isbased on beyond traditional substance single evaluation to develop concepts for health risk assessment exposures. dataalsodemonstrate These need the extentthe quality and ofmultiple chemicals trends are majorgoals ofHBM4EU. HBMreveals analysis the and ofspatial temporal and exposure of vulnerable orhighlyexposed subpopulations data valid for ofEurope, whole the identification the inEurope.data are Exposure currently fragmented to elucidate ofexposure impact the onhealth. HBM science-policy transfer, research HBMstudiesand research programmes. areactivities Majorfieldsof led by key players ofnationalHBMstudiesand Israel, isorganised and around 16work packages 28countries, 27 European countriesfrom plus organisationsHBM4EU consists of109partner evaluation ofexisting measures. design ofnew chemical policiesaswell asthe results development are further usedinthe and onwardsof planning willensure thatHBM4EU state the communication withpolicy makers from humanexposure torisks chemicals. Intensive from pathways. They basis will serve asthe to assessthe allsources aggregatethe by and exposure all from Human biomonitoring datasupplyinformation on chemicals, soprotect and humanhealth inEurope. knowledge, to inform safe the of management overarching goal ofHBM4EUisto generate new improve policy inenvironment health. and The generate knowledge the policy makers to need HBM4EU follows aninnovative approach to International Society ofExposure Science (ISES). 2014 has beenGovernmental she Councillor ofthe European humanbiomonitoring study. From 2011 to on aEuropean Scalepreparing a piloting and Consortiumthe to Perform HumanBiomonitoring HBM projects ESBIO, DEMOCOPHES COPHES, and Task Force. was She work package leader EU inthe OECDof the Endocrine Disruptor Assessment and 2006 to 2010 chair and vice-chair levels from and strategies OECD atnational,EUand guidelines and been involved development inthe ofassessment Nuclear and Building Safety has (BMUB)).She for Environment, the Ministry Nature Conservation, Association (VCI) Industry Chemical Federal the and HBMcooperation the and between German the Germanthe HumanBiomonitoring Commission, Germanthe Environmental BankESB, Specimen Program (German Environmental Survey GerES,

DAY 2 • 19 September 32 Advancing risk science assessment -HumanHealth Daniel Doerge oestrogens endogenous and ofexposuresassessment to environmental Internal dosimetrics enableholistic oestrogen receptor-mediated BPA, effects from studies inrodents. plausibility the Inaddition, of toxicologicalhealth-based guidance values from chemical-specific factors for usein computing rodent canalsoprovide human models and from range. outputsfor modelled The internal dosimetry foodscanned are consistently low inthe picomolar withanaverageindividuals orhighconsumption of for BPA. Circulating concentrations ofBPA in hasbeenincorporatedstages into PBPK models exposures during early adult and neonatal life primatesnon-human humansthatincludes and rodents, body ofpharmacokinetic evidence from especially during perinatal the period. Alarge associated oestrogenic chemical A(BPA), bisphenol exposure toadverse food the contact- effects from activityassessment hascentred potential onthe for diseases. For example, extensive research risk and humansthatoverand leads time to anumber of normalimpact endocrine inanimals function to affect soadversely and signalling genomic to oestrogen receptors to asufficientdegree endocrine-activethat some compounds bind health focus. Thisfocus isbased onahypothesis environment the diet and public isanongoing Exposure to oestrogenic compounds through the Contamination Toxicology and (2006–2013). served asEditor-in-Chief for Archives ofEnvironmental Environmental Protection Agency 2014). Healso (2008, Organization (2005, 2010, 2016), US the and Food Safety Authority (2008–2016), World the Health committees advisory assessment for European the thiswork. DrDoerge hasservedonchemical risk from than 280peer-reviewed publicationshave resulted experimental animaltoxicityrisks from testing. More minimise uncertainty extrapolation inthe ofhuman humanbiomonitoringand withPBPK to modelling safety research integration isthe oftoxicokinetics Acommonrisk strategy assessment. inthisfood pharmacokinetics chemical and DNAadducts; and that emphasisehighthroughput determinations of applicationsofmodern arsenic; massspectrometry inorganicA, and isoflavones, bisphenol acrylamide, of toxicity; thyroid toxicology; toxicology ofsoy have been:chemical biochemical and mechanisms HisareasArkansas, ofresearch USA. specialisation Center for Toxicological Research inJefferson, USFoodthe DrugAdministration’s and National DivisionofBiochemical inthe Chemist Toxicology at EFSA JOURNAL |SUPPLEMENT ,USFood &DrugAdministration 1992, he hasbeenaResearch he 1992, Universitythe ofHawaii. Since Environmental at Biochemistry Assistant/Associate Professor of California, Hewas Davis, USA. University of degree from State University aPhD and Oregon BSdegreethe from Daniel R.Doerge was awarded Environment andRisks Frédéric Bois generation risk assessments pharmacodynamics inAOPs for next Integrating pharmacokinetics and Administration, European the and Commission USOccupationalthe Safety Health and Health, USEnvironmental the Protection Agency, DrugAdministration,and NationalInstitute the of at INERISmany research projects for USFood the Berkeley, Lawrence atthe Berkeley Laboratory and contact usesissafe. that exposure to approved BPA food resulting from conclusions regulatory ofmost bodiesworld-wide pregnant inordinary actions women, reaffirms the implausibility (2)the and ofobservable oestrogenic realisticminimal internal doses; exposures from PBPKand approaches modelling thatindicate evidence comprising: classical pharmacokinetic (1) would Aconsistent alsobenegligible. bodyof pregnant women suggestthatBPA interactions oestrogensendogenous innormally cycling non- women. Similarly, receptor-binding the levels of oestrogensendogenous present pregnant inthe interindividual variability activity inthe from with BPA were dwarfed by intraday the and DDZand BPA. and Also, interactions minor these were even lower oestrogens, for GEN dietary the were consistently lessthan0.01. Moreover, RRvalues RRvaluesERβ. The for remaining the oestrogens RR values for E2 were 0.243 for 0.167 ERαand for ERβreceptors,ERα and respectively). median The pregnancy RRvalues (median of0.746 0.794 and for E3 was potent most the serumoestrogen during E4, Likewise, GENorDDZ. based RRvalues, onthe orE3E2, three and orders lower ofmagnitude than BPA was five orders lower ofmagnitude thanE1, to FROfor median The beconsidered important. increment ofnormal intraindividual dailyvariability activity to shifttotal oestrogenicity by ameaningful that serumBPA mustcontributeadded sufficient were to made critically evaluate hypothesis the ofpregnanta cohort women. comparisons These proteinsof serumbinding albumin)in (SHBGand oestrogen receptors presence ER β) inthe (ERαand relative and (FRO) responses (RR)for activation of receptor occupancy calculations offractional estetrol (E4)], was evaluated mathematical using estradiol (E2), estriol (E3), fetal the and liver-derived (DDZ)], hormones endogenous and [estrone (E1), oestrogensBPA, [genistein dietary (GEN),daidzein based onmeasurements inserumand/or urine of ,French NationalInstitute for Industrial at the Universityat the ofCalifornia at risques (INERIS). Hehasdirected, l’environnement industriel etdes L’Institut nationalde currently Research Director at Heis riskand assessment. pharmacokinetics, toxicology internationally known expertin Frédéric Y. Boisisan

DAY 2 • 19 September 33 Advancing risk science assessment -HumanHealth relationships for aromatase were collected (uptotime 2years). Invitro concentration–inhibition predict internal their concentration of asafunction intake chemicals dispositionofthe and was used to ToxCast ExpoCast and databases. APK of model aromatase inhibitors present USEPA bothinthe exposures to millions ofpotential mixtures of86 high-speed computer code, we simulated random dynamicsofwomen’sthe cycles. menstrual Using of random mixtures ofaromatase inhibitors on present ourrecent PK/PD effects ofthe modelling Toco-exist. illustrate above the considerations, Iwill for quitethat, various awhile,the approaches will Research isvery active areas inthose itislikely and pharmacology, butmuch less sointoxicology. often model, effectas the compartment usedin rangea whole ofpharmacodynamic such models, more restricted applications.In-between, there is might besimplerto develop, butthey may have regression relationships orBayesian networks) hungry. (such Statisticalmodels aslinked non-linear Yet, they canbeextremely complex data and likemechanistic, physiologically based PK models. toxicology which models, are fundamentally purposes, we would probably favour systems known present atthe For time. extrapolation toolsbest mathematical to useare precisely not Given potential their complexity, numberand the AOP are models actively alsobeing developed. been considerably improved over lastdecade. the complex withexperimental models datahave also for methods the fast calibration simulationsand of projectsin ongoing such asEU-ToxRisk. Inparallel, ofinvitromodels systems developed isalsobeing ecological risk series Awhole assessments. ofPK of azebrafishmodel, useable for humanand newof the invitro systems. We have example the are now developed being to address complexity the bodies have dramatically improved, butnew models distribution ofchemicals human inanimaland (PBPK) turn last10years. inthe Modelsofdrug hasdefinitelymodelling taken aphysiological for invitro dataintegration extrapolation, and PK pathway Inresponse to (AOP) need the framework. integrationand adverse withinthe outcome throughput high-content and dataintegration, quantitative invitro to invivo extrapolation, high- are emerging thatwe willfocus oninthistalk: inter-individual variability. Yet, new challenges route of impact the orassessing adjustments for low-doseimportant extrapolation, exposure Inany hasalways case,modelling meet. been into systems toxicology, pointwhere atthe they way. We tend towards two afusionofthe disciplines (PD; related to dose–response) inarather simplistic to exposure pharmacodynamics and assessment) often dividedinto pharmacokinetics (PK; related Relevant assessment. and are activities modelling ofrisk aspects analysis important most ofthe some Quantitative analysis ofdataare modelling and invitrodisruption and to invivo extrapolation. quantitative AOP withapplicationto models, endocrine on Bayesian for abinitiomethods and PBPK and ToxRisk, OpenRiskNet).Hiscurrent research focuses (currently, projects Euromix, StemBANCC, EU- EFSA JOURNAL |SUPPLEMENT Paolo Vineis exposomeThe inpractice risk assessment. approach, suitablefor high-throughput ranking and endocrine disrupters withapredictive toxicology possibility to predict large-scale mixture effects for henceand fertility. results These demonstrate the predicted to have potential onovulation, impacts per cent combined ofthe exposure scenarios were chemicals never ledto such effects. However, afew ovulation were predicted. Exposures to single noticeable (eventually reversible) effects on leading to over 10%inhibitionofestradiol synthesis, in women. At aromatase inhibitor concentrations hypothalamus–pituitary–ovarian control ofovulation into hormonal ofthe model amathematical resulting total aromatase inhibitionwas input ToxCastfrom corrected and for cytotoxicity. The http://www1.imperial.ac.uk/medicine/people/p.vineis Centre for Environment Health and atImperial College. Exposomethe Health and MRC-PHE ofthe theme Epidemiology, HuGeF Foundation, Torino, leads Italyand director Genetic UnitofMolecularand ofthe USNationalCancer the and Institute. Heisthe Leverhulmethe Cancer Trust, MRC, Research UK, Packages. hasattracted he Inaddition grants from Transphorm networks, inwhich hasledWork he Envirogenomarkers, Hypergenes, ESCAPE and European Commission GENAIR,ECNIS2, funded international research projects, such asthe Principal Investigator/Co-investigator ofnumerous Lifepath (valued at€6 million,started in2015). Heisa in 2012) Horizon the and project 2020-funded Exposomicsfunded project (valued at€8.7m, started currently coordinating European the Commission- experience inleading International projects. Heis Council Professor ofIARC. Vineis hasextensive (IARC,WHO). He has been a member of the Scientific Internationalat the Agency for Research onCancer Assessment) Ethics ofthe vice-chair and Committee National Academy ofSciences on21stCentury Risk committees (including Committee the US ofthe of various international ethics scientificand Lancet Lancet, Genetics, Oncology. Heisamember as leading author) injournals such asNature, Nature diseases. Hehasmore than800publications(many effects ofclimate change onnon-communicable epidemiological studiesaswell the asstudying inlarge epigenetics) and metabolomics ,Imperial College ’omic platforms (including intermediate biomarkers from complexrisk, exposures and examining biomarkers ofdisease mainlyfocus activities on exposomics. Hislatest research epidemiologyand molecular researcher fieldsof inthe Professor Paolo Vineis isaleading

DAY 2 • 19 September 34 Advancing risk science assessment -HumanHealth Bob van deWater methods testing strategies new using approach EU-ToxRisk: towards new chemical safety Epidemiol, 41(1):24–32. Wild concept to CP, utility. Theexposome: 2012. from IntJ Epidemiol Biomarkers Prev., 14(8),1847–50 exposure measurement inmolecularepidemiology. Cancer “”exposome””: theoutstandingchallenge ofenvironmental Wild CP, 2005. Complementing thegenomewithan 220(2 A),142–151 Pt Design oftheEXPOsOMICS project.IntJHyg Environ Health, CP; EXPOsOMICS Consortium, 2017. Theexposome inpractice: Phillips DH,Probst-Hensch Vermeulen A, N,Scalbert R,Wild KleinjansJ, KogevinasZ, M,Kyrtopoulos Nieuwenhuijsen M, S, Vineis P, Chadeau-Hyam M,GmuenderH,Gulliver J, Herceg and disease risks. Science, 330(6003), 460–1. SM,SmithMT,Rappaport 2010. Epidemiology. Environment References recent projects field. inthe examples from Smith, 2010; Wild, 2012; Vineis etal.,2017). Iwillshow environment inhumandisease and (Rappaport offers aconceptual leap role the instudying ofthe conception onward, over acomplete lifetime, and radiation psychosocial and component from limitednot to, chemical biological agents, agents, avariety ofsourcesexposures including, but from exposomeThe concept refers to totality the of exposome inchemicals detectable inbiospecimens. the Smith(2010) and functionalised who Rappaport concept was expanded by others, particularly population-based studies(Wild, 2012). original The detailed development inrelation to itsapplicationto proposed, initiallyby Wild (2005), withmore recent such difficulties, the concept ofthe ‘exposome’ was understanding environmental hazards. To address complicates process the ofdelineating and responseand to environmental exposures further factors other and thatmodulate susceptibility unknown interaction withunderlying genetic intraindividual variation. complex The partially and byand considerable spatial, temporal and accurately and in defining, measuring exposures disease isalsolimited by technical the difficulties unravelling The action. ofenvironmental causesof latency periods largely and unknown of modes of environmental contaminants/pollutants, long of hazards thatmay exist, typically the low levels contributors to thiscomplexity are diversity the chronic, diseases. non-communicable main The pollutants iscomplex, inrelation particularly to identificationofhazardousThe environmental research isfocused mechanistic onthe uncovering EFSA JOURNAL |SUPPLEMENT of DrugDiscovery Safety. and His Research chairs and Division the Academic Centre for Drug Safety Sciences Leiden atthe has beenfullprofessor for Drug University in1995.Since 2006 he Leiden (cum laude)from University) received hisPhD Bob van deWater (Leiden ,Leiden University understanding ofchemical toxicity. risk ofchemicals assessment based onmechanistic hazardstrategies and to enablereliable, animal-free authorities. finalgoal The is to deliver testing stakeholders aswell asvarious European regulatory cosmetics, (agro)chemical, pharma industry case studiesare supported guided by and both motor deficits.Importantly, inthe activities the of nigra striatal neurons leading to parkinsonian mitochondrialof the respiratory chain complex 1 to AOP assessthe pathway related to inhibition applicationofNAMs (iii)the analogues;and acid predictionthe ofteratogenic effects ofvalproic steatosis induced by valproic analogues;(ii) acid (i)microvesicularfor of: assessment the liver AOPs include and e.g. applicationofNAMs the Caserisk studiesare assessment. centred around NAMsinchemicalof these hazard ultimate and overall ofthe assessment the applicability domain variousthe casestudiesallows NAMsindefined reproduction toxicity (DART). integration The of systemnervous toxicity, aswell asdevelopmental/ toxicity (RDT) targeting liver, either kidney, or lung case studiesare focused onrepeated dosesystemic chemicals withlittle background information. The hazardbeginning risk and strategies assessment of toxicokineticand the knowledge; (ii)from and read-across procedures incorporating mechanistic studies, ultimately (i)pragmatic, establishing: integration different ofthe NAMsinvarious case bioinformatics PBPK and We modelling. test the in silico cellular QSARmodelling, toxicology, united allrelevant scientificdisciplines covering To accomplish EU-ToxRisk thisthe project has new non-animal using approach (NAMs). methods mechanism-based integrated testing strategies forassessment by 21stcentury the implementing establish aparadigm shiftintoxicity testing risk and European programme ‘flagship’ vision withthe to large-scaleThe EU-ToxRisk project isanintegrated 3Dphenotyping.and based automated quantitative-cell biological2D Node, ascreening facility for systematic imaging- Eu-BioImaging Dutch HighThroughput Microscopy TransQST eTRANSAFE. and Healsoleads the supported by Innovative the Initiatives: Medicines participates intwo translational drugsafety projects quantitative humanchemical safety He assessment. alternative-to-animal testing strategies for EU-ToxRisk aEuropean project, project flagship for for safety testing. Heiscoordinator H2020 ofthe quantitative systems approaches biologymodelling microscopy. dataare These integrated in adverse automated using drugaction live-cell for 3Dapplicationto 2Dand quantitatively monitor used to establishfluorescent reporter-cellmodels on liver kidney and toxicity. Molecularinsightsare applicationof’omicsthe approaches withafocus of chemical-induced target organ adversity through

DAY 2 • 19 September 35 Advancing risk science assessment -HumanHealth Anna Price in vitro model developmental neurotoxicity human using Assessment ofchemical mixture-induced and preservatives.and examples These illustrate that food additives including flavourings, colourings such aspesticides,food contact materials and multiple regulatory silosonfood food and quality, chemical pesticides.These and metals to belong chemicals, persistent organic pollutants(POPs), to different chemical classes including industrial developmental neurotoxicity (DNT)effects belong thatareChemicals known to trigger specific Systems Springer, HumanaPress, NY, 2015. Humana Press, NY, 2011 InVitro and Toxicology by Springer: Cell Culture Techniques. Neuro-methods, journals, isaco-editor she and oftwo books published many haspublished She papers inpeer-reviewed Applied Pharmacology. editorial board aguesteditor and ofToxicology and ofNeurotoxicology isamember She journal developmental adult and neurotoxicity evaluation. ACUTE-ToxARTEMIS, asaleader ofWPs linked to SEURAT (ScreenTox), PREDICT DENAMIC, IV, EU integrated FP7projects FP6and including wasShe alsoinvolved of management inthe vitro datafor regulatory DNTtesting. application ofinvitro assays interpretation and ofin on developing OECD Guidance for Document OECD ofthe isamember She steering committee for different regulatory purposes. Testing Assessment and relevant to DNTevaluation Outcome Pathways Integrated and Approaches to strongly involved development inthe ofAdverse mRNAmeasurements.and Recently, hasbeen she analysis, microelectrode arrays (MEAchips), proteins emergingapplying technologies including ’omics pluripotent stem cells-derived neuronal/glial models, invitrousing approaches based onhuman-induced strategy for developmental neurotoxicity (DNT)testing Safety Alternative and isworking She Methods. ona Consumers Reference and Materials, UnitChemicals Currently isworking she for Directorate F:Health, neuropathology of Parkinson’s and Alzheimer disease. and physiology role in system the central nervous (Cambridge, working nitric UK) University on oxide of Cambridge of Biochemistry at the Department Research Centre worked she Italy) in (Ispra, (JRC) 2002 Before joining the European Joint Commission EFSA JOURNAL |SUPPLEMENT ,JointResearch Centre neurotoxicology. neurotoxicology. neuroscience of fields and vitro in strong research background in the of experience has she acquired a Krakow (Poland). years With over 25 Institute of Pharmacology in Sciences, of Academy Polish at the PhD in 1990 Sciences in Life Anna Price (Bal-Price) obtained her application to enhance mechanistic understanding of Bal-Price AandMeekMEB,2017. Adverse outcome pathways: References additive effects. to determine itwas whether induced by synergistic or comparison compounds, withsingle willbediscussed mixture-inducedthe developmental neurotoxicity, in afterand 14days ofexposure. During thispresentation chemicals working through ofaction asimilarmode become neurotoxic inmixtures, especiallyfor the concentrations (LOAECs) chemicals ofsingle concentrations, below lowest-observed-effect datasuggestthatlow, obtained The non-/cytotoxic h) orlong-term exposure days (14 invitro). outgrowth synaptogenesis and after short-term (72 derived neurotrophic factor (BDNF) level, neurite synergistic, oradditive antagonistic effects on brain- that were undergoing differentiation to determine were assessedonhumanneural precursor cells (administered chemical asasingle orinmixtures) effectsThe selected ofthe compounds DNT AOPs (Bal-Price 2017). Meek, and adverse outcome identified inthe existing frequent of learning inchildren memory and most thatisthe outcome pathways (AOPs) relevant to impairment with common key eventsadverse identifiedin neurodevelopmental processes thatoverlapped in vitro assays were anchored to selected the human brain development. Moreover, applied the differentiation) mimicking critical ofthe stages morphological/functional neuronaland glial and processes (including cell proliferation, migration a chemical onkey impact neurodevelopmental this invitro makes model itpossibleto evaluate humaninduced pluripotent stem cells as from mixed culture ofneuronal glialcells and derived Therefore, inthisstudywe proposed to usea brainof the ofexposure. time atthe (dose, duration) developmental butalsoonthe stage outcome kind onlyonthe not depends ofexposure induced by chemicals neurodevelopmental isthatthe 2014). Achallenge for evaluation the ofDNTeffects pregnancy (Schlumpf etal.,2010; deCock etal., to multiple chemicals occurs inbabies and during (PCBs), confirming thatsimultaneous co-exposure with POPsincluding polychlorinated biphenyls (including UVfilters parabens, phthalates), together regulated withthose pesticides, along ascosmetics been found to contain chemicals regulated as for Indeed, time. at the example, breast milkhas co-exposedindisputably to more chemical thanone is strongly advocated asinfants children and are mixture risk (MRA)for assessments DNTevaluation, even synergistic. Therefore, of implementation the mixture effects may beadditive or, cases, insome potentmost chemical single inamixture, that and effects’ canbegreater than effects triggered by the documented existing inthe literature that‘mixture currently considered. At itiswell time same the across different regulatory domainsare not thatcombinedand effects chemicals ofthese by various chemicals may bedifferently regulated common, similarorrelated toxic effects triggered

DAY 2 • 19 September 36 Advancing risk science assessment -HumanHealth Pablo Steinberg experience food/feed: GRACE the G-TwYST and Assessing safety the modified ofgenetically Chemosphere, 81,1171–1183. human milk:correlation ofUVfilters withuseof cosmetics. phthalates, organochlor pesticides,PBDEs, andPCBs in 2010. Exposure patternsfragrances, parabens, ofUVfilters, H, Mascher D, Vokt Birchler C, MandLichtensteiger W, Schlumpf M,Kypke K,Wittassek M,Angerer J, Mascher prospective study. cohort Environmental Health, 13, 106. in relation to thyroid hormone levels ininfants –aDutch PrenatalM, 2014. exposure to endocrine disruptingchemicals de Cock M,deBoerMR,Lamoree M,Legler Jandvan deBor neurotoxicity. Pharmacology &Therapeutics, 179, 84–95. of Nutrition andFood Sciences in the USA. The 1983NationalResearch The Sciences USA. inthe Council, anaffiliate National ofthe Academy of RedBook)by National Research the so-called Federal Government: Process the Managing (the RiskAssessment seminalreport on the inthe classicalThe risk paradigm assessment isbased Karlsruhe, Germany. Federal Research Institute ofNutrition Food, and since 2017 President MaxRubner-Institut, ofthe Veterinary Hannover, Medicine Germany; Toxicology Chemistry, Analytical and University of 2008–2017 Director Institute ofthe for Food Hannover, Germany; Chemistry, University ofVeterinary Medicine Testing, Institute for Food Toxicology Analytical and Replacement/Complementary to Methods Animal 2008–2017 Full Professor for Food Toxicology and Science, University ofPotsdam, Germany; 2002–2008 Director Institute ofthe ofNutritional University ofPotsdam, Germany; Professorship) Institute atthe ofNutritional Science, 1998–2008 ChairofNutritional Toxicology (Full University Germany; ofMainz, Research Council Institute atthe ofToxicology, German the 1996–1998 Heisenberg Fellowship from Toxicology, University Germany; ofMainz, 1988–1995 Research Group Head Institute atthe of Toxicology, University Germany; ofMainz, Humboldt-Foundation to work Institute atthe of 1986–1987 Scholarship Alexander ofthe von Aires,Buenos Argentina; EFSA JOURNAL |SUPPLEMENT ,Federal Research Institute Biochemistry, University of Facultythe ofPharmacy and 1985 PhDinPharmacology at Aires,Buenos Argentina; Biochemistry, University of Faculty ofPharmacy and atthe studied Biochemistry 1976–1982 Pablo Steinberg assessment and described and assessment two possiblescenarios: analysisand ofsuch oral 90-day for GMOrisk Committee Guidance for studydesign the general principles described EFSA inthe Scientific EFSA provided onhow instructions to applythe 2011). Inalater explanatory 2014), statement (EFSA, food/feed whole 90-day studiesinrodents (EFSA, guidance for ofprotocols establishment the for Scientific Committee developed principles and European the Commission,request EFSA’s from feed for transformation single events. Following a rodent90-day feeding GMfood/ whole studyonthe fullyeffectivebecame requires and amandatory feed inaccordance withRegulation(EC) 1829/2003 authorisation modified ofgenetically food and (EU) No. 503/2013 onapplicationsfor EUmarket 8December thatonthe mention 2013 Regulation animal studies.Inthiscontext, to itisimportant asregards(GM) plants,particularly useof the modified genetically riskassess the derived from above-mentioned paradigm canbeappliedto very controversially the discussedissueiswhether ofchemicals thousands since 1980s,a the from process hasbeenusedto risk assessthe emanating (4)and risk characterisation. Whilethis four-step response (3)exposure assessment; assessment; hazardrisk (1) assessment: identification;(2)dose– Council identified report four steps integral to any of genetically modified crops modified of genetically (van Dijk etal., 2014; valuepossible added overall inthe risk assessment approaches were performed to evaluate their Moreover, ’omics aswell asinvitro (cell culture) Zeijenkovaal., 2014; etal.,2016; Schmidt etal.,2017). isogenic varieties were performed (Zeijenkova et MON810 maize varieties several and different near- a 1-year feeding trial withtwo modified genetically feeding GRACEthe trials 90-day project, aswell as of above-mentioned EFSA frame Inthe documents. testingthe chemicals ofsingle conversely and the OECD published hand one the Test for Guidelines was conducted inrats by taking into account on chronic toxicity aswell ascarcinogenicity testing ofGMfoodassessments feed. and Subchronic and information they provide for health the risk how suitablethey are whatusefulscientific and maize modified genetically varieties to determine alternative invitro withtwo methods different Testing), performed animalfeeding trials and plants modified (Genetically Two Year Safety Communicationand ofEvidence) G-TwYST and projects,EU-funded GRACE (GMORiskAssessment rodents 2013). Two food/feed withwhole (EFSA, chronic toxicity and/or carcinogenicity studiesin futureaid the ofprotocols establishment for EFSA alsoprepared that ascientific report would European the Commission,Upon request from • • available, i.e. potential no risk hasbeenidentified. scenario specific no 2–when is hypothesis potential risk(s); crop) modified genetically the have identifieda agronomic-phenotypicand characteristics of comparative compositional ofthe assessment available, i.e. preceding the analyses (the scenario aspecific 1–when is hypothesis

DAY 2 • 19 September 37 Advancing risk science assessment -HumanHealth of Toxicology, 90, 2531–2562. rats (EU7th Framework Programme project GRACE). Archives genetically modifiedmaize MON810 variety in Wistar Han RCC Zeijenkova D, One-year etal.2016. oral toxicity studyona Archives ofToxicology, 2289–2314. 88, RCC rats (EU7th Framework Programme project GRACE). genetically modifiedmaize MON810 varieties in Wistar Han Zeijenkova D, Ninety-day etal.2014. oral toxicity studiesontwo Toxicology and Pharmacology, 70, 297–303. transcriptomics profiling andaone-class classifier. Regulatory van Safety DijkJ, etal.2014. assessmentofplantvarieties using modified MON810maize varieties. Frontiers8, 222. inGenetics, two feeding 90-day studiesinrats usinggenetically from Sharbati J, etal.2017. Transcriptomic analysis ofintestinal tissues Food andChemicalToxicology, 50, 4221–4231. herbicide and aRoundup-tolerant geneticallymodifiedmaize. LongSéralini etal.2012. term GE, toxicity ofaRoundup Toxicology, 91,1977–2006. with geneticallymodifiedmaize MON810in rats. Archives in of observedgroup differences infive oral toxicity studies Schmidt K,etal.2017. Variability ofcontrol dataandrelevance efsa.2014.3871 EFSA Journal 25pp.assessment. 2014;12:3871, doi:10.2903/j. oral toxicity studyinrodents onwholefood/feed for GMOrisk Scientific Committee on conducting repeated-dose 90-day statement for theapplicability oftheGuidance oftheEFSA EFSA (European Food Safety Authority), Explanatory 2014. EFSA Journal 2013;11:3347, 18pp. doi:10.2903/j.efsa.2013.3347 on theapplicability ofOECD TG 453 to wholefood/feed testing. EFSA (European Food Safety Authority), 2013. Considerations 10.2903/j.efsa.2011.2438 on wholefood/feed. EFSA Journal 2011;9:2438, 21pp. doi: conducting repeated-dose oral 90-day toxicity studyinrodents EFSA (European Food Safety Authority), 2011. Guidance on References Innovationand (RRI)principles were considered. ofstakeholdersengagement ResponsibleResearch and feeding trials willbepresented. Transparency, statistical analysis inrodent dataobtained ofthe Moreover, new developments particular inthe as well asinvitro techniques) will behighlighted. limitations ofpresently available new tools (’omics be discussed.Inthiscontext, advantages the and have beenidentifiedinpreceding not analyses) will case thatrelevant changes and/or specifichazards cropsmodified EFSA’s under scenario 2(i.e. Inthe risk ofthe of genetically assessment frame in the as well value added asthe ofrodent feeding trials crop modified genetically the to be tested, etc.) design (e.g. choice rodent ofthe strain, ‘dose’ of research study ofthe aspects projects, particular experienceon the two inthese gained EU-funded G-TwYSTand projects willbesummarised. Based different experimental approaches GRACE inthe NK603. Inafirst step,the of mainfindings the study inrats maize modified genetically withthe a combined 2-year chronic toxicity/carcinogenicity tasks,of other two feeding trials 90-day aswell as G-TwYST performed, consortium anumber among maizemodified NK603 (Séralini etal., 2012) the long-termon the toxicity genetically ofthe account possibleconcerns raised by apublication food/feedwhole 2013) taking and testing into (EFSA, applicability OECD ofthe Test 453 Guideline to 453 aswell scientific asthe report by EFSA onthe 2014), OECD the Teststatement (EFSA, Guideline Sharbati etal.,2017). EFSA Basedonthe explanatory EFSA JOURNAL |SUPPLEMENT Frits Koning disease toxicity In silico tools to predict potential coeliac essence, inpatients withCD, system immune the by disease-associated the HLA-DQ In molecules. recognise gluten presented peptidesonlywhen duodenum. Importantly, Tcells CD4+ these present laminapropria inthe affected of the inflammatory gluten-specific T cells CD4+ are In patients, inhealthy butnot pro- individuals, remaindersthe are usuallyHLA-DQ8 positive. majority ofCDpatients expresses HLA-DQ2.5 while system. immune the large The to Tcells from present peptidesand these short bind molecules chain (DQB1). Like HLA-DQ molecules allHLA composed (DQA1) of analpha-chain abeta- and HLA-DQDQ molecules. are molecules dimers man. MostCDpatients express HLA- particular calledhumanleukocytegenes, in antigens(HLA) associated response immune withparticular CD hasastrong component genetic asitis grains. these like proteins from contain wheat, barley ryeorgluten and gluten- and exclusion the diet implying ofallfood products that onlyavailableThe treatment isalifelong gluten-free patients, although exceptions have beenreported. Oat (Avena sativa) isgenerally considered safe for barley (Hordeum vulgare) rye(Secalecereale). and spp.) to and gluten-like hordeins secalinsin and response to gluten proteins inwheat (Triticum is causedby anuncontrolled intestinal CD4T-cell thrive, diarrhoea stomach and ache. disease The symptoms including malabsorption, failure to intestinal surface, resulting in a variety ofclinical intestine characterised by flattening ofthe Coeliac isadisease disease small ofthe (CD) systemimmune inInflammatory Bowel Diseases. unravel involvement the innate ofthe adaptive and work flow useshighdimensional he cytometry to HLA-DQ coeliac and disease. recent Inhismost basismolecular for associationbetween genetic the recognised by disease-related Tcells, providing a are disease causative how and they arefragments his work itisnow well which established gluten disorders, coeliac disease Through inparticular. his contributions to fieldofimmune-mediated the with coeliac Heiswell disease recognised (CD). for topartners improve quality the oflife ofpatients doctors medical and collaborate withindustrial which food geneticists, immunologists, specialists Dutchof the Coeliac Disease Consortium (CDC)in boardadvisory scientific ofthe CEO the LUMC and Centre since 1993. chairman Heisthe ofthe ,Leiden University Medical Center the Leidenthe University Medical Blood Transfusion fte) (150 of of Immunohematology and Department inthe staff member Professor Frits Koning hasbeena Leiden, Netherlands the University MedicalCentre, Professor ofImmunology, Leiden

DAY 2 • 19 September 38 Advancing risk science assessment -HumanHealth for Environmental Medicine Ellen Fritsche be discussedduring presentation. the will plantsand modified ofgenetically assessment presented EFSA inthe guidance onallergenicity harmful sequences proteins, inother astrategy design ofaspecificstrategy potentialto identify disease-causative sequences ingluten allows the in wheat. Detailed knowledge known onthese orevenhighly homologous similarto found those hordeins secalins have and beenidentifiedthatare been reported. T-cell Inaddition, epitopes inboth low-molecular-weightand (LMW) glutenins have high-molecular-weight (HMW) as well asfrom ω-gliadins T-cell γ-and α-, the epitopes derived from dietisthusrequired. lifelong gluten-free gluten-reactive Tcells results and ininflammation.A subsequent exposure to gluten willreactivate the results memory. inimmunological Therefore, every gluten-specific T-cell response hasdeveloped, this are present. longer no Unfortunately, once a treatment T-cell asthe stimulatory gluten peptides dietconstitutes the aneffective gluten from asglutenas long isconsumed. Eliminationof pathogen, leading to apro-inflammatory response food are recognised a asifthey are derived from makes amistake: harmless the gluten proteins in guidance for document invitro DNTevaluation. OECD ofthe member expertgroup for creating a several EFSA procurements Currently, since 2014. isa she EFSA working group hasbeenworking and member on (developmental) neurotoxicity. Professor Fritsch was an has alsobeeninvolved inAOP generation for for developmental neurotoxicity (DNT)invitro. She formodels of compounds modes-of-action studying been developing species-overarching 3Dinvitro Sphere RiskAssessment Modelsand group. has She EFSA JOURNAL |SUPPLEMENT ,Leibniz Research Institute Dusseldorf where leads she the Environmental in Medicine Research Institute for IUF– affiliation withthe Leibniz Düsseldorf. hasajoint She Heinrich-Heinethe University of Environmental Toxicology within aProfessorshipholds for Professor Ellen Fritsche, MD,

DAY 2 • 19 September 39 Advancing risk science assessment -Nutrition Nutrition Advancing riskassessmentscience concern indeveloped countries. of excess predominant asthe publichealth nutrient deficiencies switchto diseases from evolve should guidelines to address the goal sessionisto ofthe explore how dietary future. dietsinthe and overarching The developments could food impact choices exploring how technological societaland in wealthy populations,aswell asat foods dietsto and humanhealth impact debate power onthe nutrients, ofsingle sessionaims atfosteringThe ongoing the nutritionspotlight inthe area. populations increased steadily, the shifting morbiditythe ofWestern mortality and type 2diabetes on impact their –and as obesity, cardiovascular diseases and related chronic diseases metabolic –such lastcentury,the prevalence the ofdiet- advice. However, lastquarter inthe of target for nutrition research dietary and compatible withgoodhealth were amain of minimumnutrient requirements nutrientand intakes, estimation the and nutrientestimation ofthe content offoods consequence, nutrient single diseases, the area for lastcentury. ofthe most As a public health concern nutrition inthe nutrientSingle deficiencies were major the EFSA JOURNAL |SUPPLEMENT Valeriu Curtui CHAIRS Andrea Germini RAPPORTEURS Jayne Woodside National Institute for Health Research Safefood. and Council, NationalPrevention Research Initiative, MedicalResearch the has current from funding nutrition widelyinthe haspublished She fieldand interventions to promote long-term change. dietary examining clinically relevant alsoin and endpoints, aPhDinveterinaryholds medicine. focused ontoxicology chemical and food safety. He Germany.and Histeaching research and activity was he atuniversities anacademic EFSA, inRomania his current role in2013. Before hisemployment with occurrence exposure infood dietary and took and up ,European Food Safety Authority ,European Food Safety Authority ,Queen’s University Belfast officer working on chemical EFSAjoined in2008 asascientific Nutrition Allergies. and Valeriu Panel onDietetic Products, to support EFSA the Scientific administrative scientific and Unitinproviding the manage HisroleNutrition Unit. isto Valeriu Curtui ishead ofEFSA’s guidance for documents EFSA risk development ofcross-cutting hasbeenworking he EFSA, on the University of Parma. Since joining assistant professor atthe was he Before EFSA, joining officer atEFSA’s Nutrition Unit. currently working asascientific Andrea Germini isafood scientist nutrition intervention studies intake, conduct the ofhuman of biomarkers to assess dietary use specialisesinthe Belfast. She Health) atQueen’s University Food Security (Centre for Public Institutewithin the for Global Professor ofHumanNutrition Professor Jayne Woodside is

DAY 2 • 19 September 40 Advancing risk science assessment -Nutrition Graham MacGregor diseases?metabolic Socratic debate: Dosugars causechronic SPEAKERS Silvia Valtueña Martinez focus onfood biomolecules. aPhDinfoodholds science technology and witha GMOs, novel foods food and Andrea supplements. ofregulatedassessment products area inthe of characterisation the and assessment safety and Authority recently. Itplays role inobesity animportant because that was consumed not inany quantity untilquite disability. source Sugarisanunnecessary ofcalories vegetables isby far biggestcauseofdeath the and and that ishighinsugar, salt fat and lacks and fruit demonstrates thatadietcontaining unhealthy food GlobalThe Burden ofDisease studyclearly drugs for treatment the ofhighbloodpressure. pharmacological ways, better alsothe and useof better ways oftreating non- patients, particularly potassium intake. Hisresearch hasalsofocused on angiotensin system, influence the and ofsalt and in hypertension, renin– ofthe importance the mechanismsthe underlying rise the inbloodpressure Professor research MacGregor’s work hasfocused on surrounding itseffects sugarand onhealth. salt, of allprocessed foods increase and publicawareness with great success to slowly reduce salt the sugar and Health) onSugar, Action and which hasbeenworking Salt Health) and WASH and (World onSalt Action and founder Chairman and ofCASH (Consensus on Action osteoporosis, diabetes cardiovascular and diseases. development ofchronic disease, obesity, namely research relationship onthe between dietand human nutrition, hasconducted and independent allergens for purposes. labelling aPhDin holds She EFSA JOURNAL |SUPPLEMENT Hypertension Society, is and as President British ofthe Blood Pressure UK,recently served London.The HeisChairman of Consultant Physician and atBarts Honorary and Medicine Wolfson Institute ofPreventive of Cardiovascular atthe Medicine Professor MacGregor isProfessor levels ofnutrients, food and values upper and tolerable intake dietetic reference foods, dietary novel foods, infant formulas/ health claims onfoods, made scientific with the evaluation of whereNutrition Unit, deals she scientific officer at EFSA’s Silvia Valtueña issenior Martínez

Queen Mary UniversityQueen Mary ofLondon ,European Food Safety John Sievenpiper diseases?metabolic Socratic debate: Dosugars causechronic significant positive associationofsugar-sweetened studieshavemeta-analyses ofcohort shown a are reached. Although systematic reviews and controlled feeding trials, different then conclusions prospective studiesand cohort of evidence from considersIf one totality the level highest ofthe levels ofintake have been usedto thisview. support levels ofexposure far beyond mean population humantrials select and models ofoverfeeding at responses. Low quality ecological studies,animal sugars dueto endocrine and itsuniquemetabolic moiety of attention hasfocused fructose onthe health target ofchronic diseases. metabolic Special Sugars have replaced fat dominant public asthe Canadian Obesity Network. Canadian Cardiovascular(EASD), Society (CCS), the and Canada, European Association for studyofDiabetes the to nutrition the committees guidelines’ ofDiabetes involved inknowledge translation withappointments papers 13bookchapters. and DrSievenpiper isdirectly Award. Hehasauthored more than150scientific Diabetes Centre Sun Life Financial New Investigator Canada ClinicianScientistAward Best and Banting and disease prevention. Hecurrently aDiabetes holds health in relation importance to chronic dietand analyses to address questionsofclinical public and controlled trials systematic and reviews meta- and (FRCPC). Hisresearch isfocused randomised onusing Fellow Royal ofthe College ofPhysicians ofCanada McMaster Universitya leading to as hiscertification by residency training at inMedicalBiochemistry completed hisMDatStMatthew’s University followed Nutritional Sciences University atthe ofToronto. He doctoral Fellowship of training Department inthe Dr Sievenpiper completed Post- PhDand hisMSc, Ka Knowledge Shing Institute atStMichael’s Hospital. Endocrinology La Scientistinthe Metabolismand and properties, iscontroversial.properties, sugar, cariogenic ofitsobesogenicand independent disease. evidence Butthe for harmful other effects of sugar intake may beassociated withfatty liver diabetes evidence some and suggeststhatexcessive in sugar-sweetened drinks isadirect causeoftype 2 suggested thatincreased sugarintake particularly is amatter ofcontroversy. Several studieshave sugar hasdirect toxic effects ofthis independently in softdrinks. Italsocausesdentalcaries. Whether giveit doesnot any feeling ofsatiation,e.g. sugars Physician in the Division of Physician Divisionof inthe asaStaff appointments also holds University ofToronto, Canada. He Lead MDProgram inthe atthe Sciences Lifestyle the and Medicine ofNutritional Department as anAssociate Professor inthe appointments holds Scientist who Dr Sievenpiper isaClinician ,University ofToronto

DAY 2 • 19 September 41 Advancing risk science assessment -Nutrition Philippe Legrand chronic diseases? metabolic Socratic debate: Dosaturated fats cause insugars. endocrine responses to fructose the foodand form rather thanany or specialmetabolic of sugars appear to bemediated by excess calories uniquely to obesity diabetes. and Any adverse effects together, sugars appear donot to contribute excess dietswithout same with the calories. Taken SSBs)are to added dietscompared (especially from comparisons sugars inwhich excess calories from alcoholic fatty liver disease) inhypercaloric glucose, insulinresistance, markers and ofnon- disturbances (increased bloodlipids,uric acid, to contribute to weight cardiometabolic gainand energy matched comparisons. Sugars onlyappear sources ofcarbohydrates likely to replace in them shown thatsugars behave worse no thanother meta-analyses ofcontrolled feeding trials have associations. Similarly, systematic reviews and breakfast cereals, many ofwhich show protective juice, yogurtand fruit of sugars including fruit, foodinclude sources important SSBs)orother (allofwhich for total sugars, sucrose, orfructose failed to show adverse same the associations meta-analyses involving have cohorts same the diseaseheart stroke, and systematic reviews and beverages obesity, (SSBs)withincident diabetes, (ISSFAL), board ofthe amember French ofthe Society for StudyofFatty the Acids Lipids and Nutrition. International ofthe Heisamember his research production fieldoflipidsin inthe CHEVREUL Medalaward inUppsala(Sweden) for recently300 publicationsonLipids, he received the precisely saturated fatty Author acids. ofmore than approach for considering lipidsingeneral, more and Safety Agency (ANSES)where proposed he anew fatty recommendations, dietary acid Food inthe French1998 ofthe committees guidelines for the chain saturated fatty Heischairman acids. since betweendistinguish /middlechain /long short nutritional interest evolution necessary the and to for 15years onsaturated fatty showing acids, their n-6/n-3 balance Hehasalsoworked inhumandiet. leading to recommendations the required onthe n-3 and n-6 fatty shared acid desaturases, same the showing conversion thatthe ofpoly-unsaturated showing ofstearic importance the desaturase, acid has worked role onthe offatty desaturases acid synthesisacid More metabolism. and precisely, he performed research offatty aspects onfundamental (Agrocampus). For more than30years, has he Research EFSA JOURNAL |SUPPLEMENT Agronomic University ofRennes Human Nutrition inthe laboratory and ofBiochemistry Professor chairman and ofthe Nutritional Sciences. Heis University Divisionof (USA)inthe post-doc atCornelland University ofParis in1987 from PhD inNutritional Biochemistry ,NationalInstitute ofAgricultural 145, 299–305. with establishedcoronary disease. artery Journal ofNutrition, associated withrisk ofcoronary events inpatients ormortality Puaschitz intake Netal.,2015. Dietary ofsaturated fat isnot American Journal ofClinicalNutrition, 103, 356–365. Investigation into Cancer andNutrition—Netherlands cohort. the type andsource offatty acidintheEuropean Prospective saturated fatty acidsandischemic heartdisease depends on Praagman Theassociationbetween Jetal.,2016. dietary Nutrition, 91(3), 535–546. cardiovascular disease, TheAmerican Journal ofClinical studies evaluating theassociationofsaturated fat with Siri-Tarino Petal.,2010. Meta-analysis ofprospective cohort Science andTechnology, 117, 1489–1499. acids: beyond epidemiologicaldata,European Journal ofLipid Legrand PandRiouxV, 2015. Specific roles ofsaturated fatty Lancet, 390, 2050–2062. five continents (PURE):aprospective study. cohort from The intake withcardiovascular disease in18countries and mortality Dehghan Metal.,2017. Associations offats andcarbohydrate meta-analysis. AnnalsofInternational Medicine,60, 398–406. supplement fatty acidswithcoronary risk: asystematic review and Chowdhury Association ofdietary, R,etal.,2014. circulating, and reference intakes (ANC)for fatty acids,2010. www.anses.fr 2010. CompleteANSES, reportontheupdate ofFrench population References statements ofSFAs toxicity oreviction. date recommendations caricatural the without old saturated fatty Hence, acids. for itstime up-to- ofindividual effects, functions specificitiesand We more need information ondoses,physiological atherogenicbeing onlyincasesofexcess. and palmitic subgroups acid were considered ones the myristic lauric, onlythe and has beenmade, and saturated among distinction guidelines, fatty acids in France Inthese ANSESguidelines. the under for saturated fatty asrecently acids, carried out currentthe recommendations nutritional dietary epidemiological datainvites areassessment of chain saturated fatty Such acids. weakness inthe even middleorlong precisely describe short, the risks are isoenergetic not isocaloric nor donot and recommendations. the supporting Mostreports in terms ofrisk suggestareassessment and ofthe new meta-analysis dataand allow abalanced view Even for cardiovascular disease (CVD) prevention, specificnutritional other and functions. have physiological roles surfactant such aspulmonary (N-myristoylation, S-palmitoylation, octanoylation) and mechanisms such asprotein acylation raftssphingolipids, for and biochemical elucidating for membrane structure inphosphoglycerides, toaddition energetic their they function, are required term In ofstructure, function. and metabolism group homogenous and as asingle anymore, in cell,in the showing thatthey beconsidered cannot all SFA have specificbiological and roles important instance. Moreover, literature the demonstrates that chain ontheir depending of metabolism for length, nutrients have poisonsand not and different types However, we mustfirst be thatSFAsreminded are atherosclerosis biomarkers incasesofexcess. health negative becauseoftheir onsome impact associated withnegative consequences for human saturatedDietary fatty (SFA) acids were usually asanexpert fortimes European institutions. Nutrition Society hasworked (SFN)and several

DAY 2 • 19 September 42 Advancing risk science assessment -Nutrition Ronald Mensink chronic diseases? metabolic Socratic debate: Dosaturated fats cause in serumLDL-cholesterol concentrations between level, individual the butalsobecauseofvariations is difficult to estimateaccurately intakes dietary at cholesterol. onlyrelated Thisisnot to fact the thatit a relationship between SFA intake withLDL- epidemiological studiesdo often show alsonot SFA intake related isnot to CHD. For example, beusedasaconclusivealso not argument that latternot beignored should findings butshould association between SFA intakes withCHD. These studies, however, have consistently not shown an cardiovascular events. Prospective epidemiological SFA withpolyunsaturated fatty reduces acids trials have suggested thatreplacement of Further,CHD risk. alsorandomised controlled cholesterol isanaccepted biomarker to estimate we have to rely often onbiomarkers LDL- and concentrations. For recommendations, dietary that amixture ofSFA increases LDL-cholesterol controlled intervention dietary studies from based overwhelming onthe is partly evidence saturated fattyenergy (SFA). acids from Thisadvice istodisease (CHD) consume more not than10%of forguidelines reducing risk the ofcoronary heart keyOne recommendation inmany dietary orhealth guidelines dietary claims. information development the supporting offoods, studiesistoof the provide evidence-based performance plays acentral role. ultimate The aim cerebrovascular asrelated function to cognitive vascular Also, function. inrecent projects systemic metabolism and inflammation,HDL ofresearchline interplay onthe between low-grade researchers.with other Thishasresulted inanew incollaboration resistance) are studied,frequently (e.g. low-grade systemic inflammation,insulin- ofchronic aspects possible, other stress metabolic vascular Whenever lipidmetabolism. and function focus isoncomponents thataffect peripheral disease. non-invasive Using techniques, strong the disturbances involved inetiology ofcardiovascular applied to understand studyand metabolic conditions is ‘normal’ studiesunder from obtained mechanisms underlying effects. these Knowledge unravel biochemical the molecular and physiological effects, butalsoto functional and volunteers. Studiesare onlyto not designed lookat studies have beencarried outwithhuman cardiovascular disease. For intervention this,dietary chronic stress, metabolic related particularly to EFSA JOURNAL |SUPPLEMENT ,Maastrick University components dietwith inthe nutritive non-nutritive and relationshipsthe between researchHis primary interests are an MScdegree inepidemiology. Wageningen. has he Inaddition, Agriculturalat the University in MSc degree inhumannutrition Ronald P. Mensinkreceived an of Nutrition Science &Policy Dariush Mozaffarian patternsdiets vs dietary whole diseases: popular and single-nutrient preventionDietary ofchronic metabolic appointed as Dean DrMozaffarian atTufts in2014, Harvard.Doctorate Before being inPublicHealth from University the ofWashingtonan MPH from a and University the and ofWashington. Healsoholds Stanford cardiovascular and medicine from medicine clinical Alpha),and (Alpha Omega training ininternal Columbia Stanford (PhiBetaKappa), anMDfrom from Dr Mozaffarian received hisBSinbiological sciences Most InfluentialScientificMinds. ReutersThomson World’s ofthe himasone named Time many and Magazine, outlets. In2016, other Post, Wall Street Journal, NationalPublicRadio, been featured New inthe York Times, Washington Organization, United and Nations.Hiswork has Burden ofDiseases study, World Health governments, American Heart Association, Global roles includingadvisory for Canadian US and the burdens. DrMozaffarian hasserved innumerous innovations policiesto and effectively reduce these globally, onevidence-based and systems disease, and diabetes, obesity and USA, inthe priorities dietary on the to reduce cardiovascular has authored more than300scientific publications science, future leaders, real-world and He impact. Friedman School’s missionisto produce trusted by high-glycaemic index carbohydrates. unsaturated fatty ispreferred acids over substitution intakes –substitutionofamixture ofSFA by cis- asSFAthat –aslong intakes isabove recommended studies. For now, convincing most the evidence is questionsmustbeansweredoutstanding infuture relatednot to lipoprotein These metabolism. differentthe SFA may differently affect pathways biomarker(s)of) isto predict CHD. Inaddition, best(set questioniswhatthe important Another differentthese SFA have different health effects. effects,metabolic much butnot isknown whether also known different thatthe SFA are different may result indifferent effects. metabolic Itis carbohydrates by and proteins. Each replacement SFA canbereplaced by types other offatty by acids, increasing intake the macronutrient. ofanother changenot –reducing intake the ofSFA means be appreciated energy that–when intake does differences composition. Further, indietary itshould which withinindividuals, and are dueto onlypartly of nutrition in North America,of nutrition the inNorth renownedmost graduate school University, oldestand The USA. Science Policy and atTufts Friedman School ofNutrition Dean and Medicine, ofthe Professor ofNutrition and cardiologist, aJean Mayer Dariush Mozaffarian isa ,Tufts Friedman School

DAY 2 • 19 September 43 Advancing risk science assessment -Nutrition randomised trials. Several key lessonshave emerged: studies,prospective metabolic designed and cohorts been transformed well by rigorous evidence from dramatically. At nutrition time, same the science has In recent years, patterns global dietary have shifted for nutrition education,research, publicimpact. and entrepreneurialand spirit make italeading institution School’s uniquebreadth, world, withthe engagement community entrepreneurship. and service, The policy, advocacy, government, industry, publichealth, Friedman School graduates are active inacademics, humanitarian crises, food and economics policy. and systems sustainability, and global food security, interventions, communication, and media food behavior change, community organizational and datasciences,human metabolism, clinical trials, Areas offaculty expertiseinclude nutrition, molecular from and education acrosscell fiveto society. Divisions FriedmanThe School pursues cutting-edge research Black Belt (second degree) inTaekwondo. married, hasthree children, actively and trains asa cardiology atBrigham Women’s and Hospital.Heis of PublicHealth for clinically and adecade active in was atHarvard MedicalSchool Harvard and School • • • often leads to paradoxical choices dietary and isolated nutrients. Focusing onisolated nutrients foods overall and dietpatterns, rather thansingle A third key ofspecific importance lessonisthe oils, seafood, grains. whole plainyogurtand nuts,beans, vegetables, plant others, especiallyfruits, starches, grains, sugars and more and calories from foods, some especiallyfood rich inrefined from expenditure. We beconsuming should fewer calories fat production, microbiome the metabolic and brain reward, glucose–insulin responses, liver related to weight control including hunger, satiety, produce diverse effects onoverlapping pathways organisms, different inwhom foods drinks and equal invitro energy, are humanbeings complex Althoughhomeostasis. each calorie offood provides physiological mechanisms oflong-term weight foods have divergent effects ondiverse, complex obesity, allcalories are created not equally. Different Second, for long-term weight risk gainand of burdens related thanthose other to obesity alone. conditionsand thattogether produce larger health quality influences a myriad ofother risk pathways pathwaysimportant ofdiet-related disease. Diet 1980s,mayin the misskey effects based onother obesity justlike alone, afocus onbloodcholesterol clinical events. For example, afocus onweight and risk pathways prospective and trials and cohorts of of evidence including trials thatevaluate multiple any surrogate single totality the outcome, butfrom food oroverall beextrapolated not dietshould from microbiome. So, recommendations for any nutrient, energy expenditure, weight regulation the and health,endothelial liver, fat cell, function, heart and lipoproteins,insulin homeostasis, inflammation, blood cholesterol, bloodpressure, glucose– cardiometabolic risk factors, including obesity, habitsinfluence diverse First, dietary EFSA JOURNAL |SUPPLEMENT Petra KlassenWigger on food pattern consumption dietary and Food innovation consumer and trends: impact implement and evaluate and implement strategies. these to21st century now bring stakeholders together to disease greatest the Itisamong risk. priorities ofthe strategies to improve food choices reduce and provide ofstrong, uswithamenu complementary science. Advances innutrition policy and science approaches based onoutdated orinsufficient cautious aboutaccepting targets policy and dietary ofoptimalnutrition,importance we mustremain diabetesand raise awareness immense ofthe science. As global the pandemics ofobesity diets, often incomplete and based onpartial is increasingly confused by anexplosion ofpopular government policies.At public the time, same the consumer decisions,organisational priorities and This reductionist focus leads to paradoxical do contribute significantly increasingto the Demographic shiftstowards populations ageing remainshealth asignificantpublic concern globally. in undernutrition, overweight and obesity, and dualburdenThe ofmalnutrition, manifesting itself nutrition health and relevant consumer trends. alsoworksShe onunderstanding leveraging and tackle undernutrition with micronutrient fortification. Health Wellness and drove Unitshe strategy the to on, asScientific Advisor inthe Corporate Nutrition, communication for healthcare professionals. Later institute’sthe contribution to nutrition the implemented adigitalstrategy thatstrengthened Affairs NestléNutrition atthe Manager Institute she During Scientific asMedicaland functions. time her Research Centre later and indifferent marketing working indifferent first Nestlé atthe functions, than their overallthan their healthfulness. oftotallabelling calories offoods meals and rather foods loaded withstarch; mandate and sugar-free healthy foods withalittle sugarbutnot added peanutfat, nuts,tunainoiland butter; warn against dressing butwarn vegetables against withadded salad milk; recommend lean fat-free beefand milk butrecommend sugar-sweetened skimmed This produces peculiarstrategies thatshunwhole reductionist: reduce calories, total sugar. fat,added policiesinmany and guidelines cases dietary policies.Yet,dietary international nationaland based patterns target primary bethe should of formulations.industry So, improving overall food- Guatemala Nestlé joined she years ofresearch in activities Stuttgart.Hohenheim, After five University the of Nutrition from Switzerland. aPhDin holds She Research inLausanne, Wellnessand Unitat Nestlé globalof the Nutrition, Health Dr Petra KlassenWigger ishead ,NestléResearch Center

DAY 2 • 19 September 44 Advancing risk science assessment -Nutrition and ingredientand contents. To achieve goal the food manufacturers aboutsourcing, processing increasingly expecting more transparency from necessary. consumers efforts, withthese Along are about safe nutritious and food choices are For collective that, to efforts educate consumers desired behaviour change. or fat socan have and opposite the effect thanthe communicatingwhen onpack reduction insugars consumer preference canbenegatively influenced As anexample, research hasdemonstrated that healthier recommendations. dietary meet dietsand to address additionally consumer behaviour towards itisalsoimportant profile ofproducts isimportant, While reformulation to improve nutritional the recognised drivers ofconsumption. a pleasurable experience sensory are asthese well toproducts itisimportant deliver goodtaste and improvingpulses. When nutritional the profile of intake infibre, micronutrients, vegetables or e.g. nutritional diet, ofthe certain aspects increased they to come withopportunities along improve requirements, e.g. for vitaminB12oriron. Conversely, result inchallenges to nutritional certain meet environmentaland sustainability concerns, vegan dietsdriven by personal health benefits trendthe towards vegetarian, flexitarian or even toneeds beaccelerated. choices, Dietary e.g. nutrients,these palatability, whilemaintaining to reformulate products withlower levels of developmentthe oftechnological solutions diseases. To deliver above the against trends, fats, thatare associated withnon-communicable nutrients, such assugar, saturated sodium,and There are to efforts alsoongoing decrease certain vulnerable populations. foods nutrient widenthe thatmay gapin further trend to calling reduce consumption offortified world, ofthe are parts insome seeing anemerging may lead to anunbalanced For diet. example, we a balanced there diet, isarisk choices thatsome choicesWhile some inthiscontext contribute to consumer the these often perceive ashealthier. a trend towards foods’ hasincreased ‘natural and calorie intake butlow nutrient density. Recently availability, contributing to risk the ofexcessive of food beverage and choices atlow cost high and world ofthe In many parts we observe anexplosion or even astherapy for, chronic diseases isincreasing. tests, microbiome analyses metabolic and to prevent, personalised food dietand choices based ongenetic As aconsequence, for demand the more medicine. is viewed differently even sometimes and asa This influences the food culture ina way that food influencers. offline and numberofonline endless healthy what define means, eating fostered by an observe atrend ofincreased confidence to self- awareness including onnutrition health. and We resultingfingertips, inincreased knowledge and unprecedented ofinformation amount attheir advances provide consumers withaccess to an related cost for society. At digital time, same the prevalence diseases ofnon-communicable the and EFSA JOURNAL |SUPPLEMENT supports healthiersupports dietsfor society. largerof the health wellness and ecosystem that dietare ofaconsumer’s aspects considered aspart to canhelp and is needed ensure various thatthe multi-stakeholder and Aholistic impact. approach interventions are unlikely to have a long-lasting of improved health, dietsand orisolated single

DAY 2 • 19 September 45 Advancing risk science assessment -Biologicalhazards Biological hazards Advancing riskassessmentscience offer willbeexplored disseminated. and as Next Generation (NGS),can Sequencing thatnew such methodologies, opportunities to illustrate challenges the ahead. The used antimicrobialand resistance –willbe intentionally introduced to food the chain, vector-borne zoonoses, microorganisms HealthOne perspective. Three topics – a challenges to from risk assessment, threats atglobal considers scaleand the This sessionfocuses onbiologicalhazards/ complexity food ofthe supplychain. will bechallenging dueto increased the hazards Tracing risk. and threats those feedand isassociated “trade” withthe of increasingly globalised trade infood This of globalisation lastdecade. inthe technology have intensified the rate communication and in transport feedand around Advances planet. the movementand ofpeople,animals,food Globalisation encompasses spread the EFSA JOURNAL |SUPPLEMENT Prevention andControl Mike Catchpole CHAIRS Marta Hugas Marta EFSA, she worked she EFSA, for Institute the for Food and University London. professor, atImperial College London City and to asavisiting appointments, Hehasacademic 2006. 2001 Intervention Epidemiology Training (EPIET) from Committee European ofthe Programme for European projects, chaired and Steering the steering ofthe member groups for anumberof information systems development. Hehasalsobeena effects publichealth and ofmajorincidents, sexually transmitted infections, widerhealth the research interests have included HIV other and His primary difficileinEngland. C. in MRSAand were indriving instrumental dramatic the reductions London surveillance the Olympicsand systems that surveillance the managing systems for 2012 the inLondonbombings in2005, developing and and health follow-up exposed ofthose to terrorist the leadingA(H1N1) pandemic inEngland, public the epidemiological response to 2009 the influenza investigations leadership and national ofthe ofmanymanagement nationaloutbreak surveillance response, and including the ofcommunicableof management disease Hehasover 2007 until2014. 20 years’from experience wasand Forum ECDC ofthe UKmember the Advisory Centre for Infectious Disease Surveillance Control, and was Director ofPublicHealth England’s National ,European Food Safety Authority ,European Centre for Disease Before working ECDC atthe he international levels since 1991. responseand atnationaland infectious disease epidemiology doctormedical hasworked who in (ECDC), Stockholm. Heisa for Disease prevention Control and European atthe Scientist, Centre Professor Mike Catchpole isChief Contaminants Before Unit. joining BiologicalHazardsof the and head and Assistance Department, Risk Assessment Scientific and headHazards acting ofthe Unit, several positions: head of Biological EFSAjoined in2003, hasheld she Since Marta scientist atEFSA. asachief Hugasisserving Marta

DAY 2 • 19 September 46 Advancing risk science assessment -Biologicalhazards Sofie Dhollander AguileraJaime Ana Afonso RAPPORTEURS biotechnology aPhDinfood and microbiology. Master’s degree microbial and ingenetics degree hasaBachelor’s inbiologicalsciences, a Marta associate professor University atthe ofBarcelona. meat food and safety. From 1992 to was she an 2004, ledaresearchUnit and group onappliedresearch on head Food ofthe Microbiology Biotechnology and Agricultural Research Technology, and where was she sciences University atthe ofValencia in2003. biotechnology. hisPhD inbiological Heobtained plant virology, subsequentlyfood and washe aresearcher inevolutionary and genetics fermentation products. Before EFSA joining in2008, veterinary animalepidemiology. studiesand Real. isaveterinarian She specialisedinaquatic Veterinary Portuguese the Faculty Vila ofLisbonand fish farming, asa and research/lecturer assistantat assistant for hygiene animalhealth and issueson offoodinspection asaveterinary establishments, veterinary official responsible for approval and borne diseases. worked she Before EFSA, asa drafting onemerging ofscientific reports vector- others, coordination the ofworking groups the and EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority ,European Food Safety Authority chain orusedasasource of strains introduced food inthe characterisation ofmicrobial biotechnology, including the products through obtained offoodassessment feed and regulatoryspecialist inthe risk officer atEFSA’s Heis FEEDUnit. AguileraJaime isseniorscientific animal health, including, among involved inrisk on assessments Welfare where Unit, was she officer AnimalHealthfor the and EFSA in2006 asascientific Emerging Risks Anajoined Unit. Scientific Committee and officer and team leader atEFSA’s Ana Afonso isaseniorscientific assessments onanimalhealth,assessments working groups dealing withrisk Welfareand Panel its and tosupport AnimalHealth the whereUnit, provides scientific Animal Health PlantHealth and senior scientificofficer at EFSA’s iscurrentlySofie Dhollander ,European Food Safety Authority Winy Messens David Waltner-Toews SPEAKERS Pietro Stella of Veterinarians Borders/Vétérinaires without sans à Montrèal, Waltner-Toews was founding president l’environnement (CINBIOSE),Université duQuebec University the ofGhent. sciences from technology) aPhDinappliedbiological and Master’s degree inbioengineering (food ofEFSA’smember BIOHAZPanel. a holds She University. Ghent the Brussels and was She a Agricultural Fisheries and Research, Vrije Universiteit postdoctoraland researcher Institute atthe for production veterinary and epidemiology. intropical animalhealthspecialised further and Sofie graduated as veterinarian has and in1998, Sciences ofSouthVietnam untilSeptember 2007. development project Institute atthe ofAgricultural coordinator ofaveterinary research and tolerance Centre. In2005, continued she asproject where worked she International atthe Trypano- swine fever. started She carrier her African inAfrica, onemergingreports vector-borne diseases and working groups drafting the and ofscientific including, others, among coordination the of ,European Food Safety Authority ,European Food Safety Authority previously worked asascientist Winy EFSA joined in2010 and areathe offood microbiology. Panel onBiologicalHazards in tosupport EFSA the Scientific where provides she scientific Hazards Contaminants and Unit, officer atEFSA’s Biological Winy Messensisseniorscientific la santé, lasociété et Interdisciplinaire surlebien-être, Centre deRecherche Health-Canada (CoPEH-Canada), Ecosystem Approaches to Community ofPractice for Associate Researcher atthe Universityat the ofGuelph,and A University Professor Emeritus publichealth.epidemiology and a Master’s degree inveterinary sector. Pietro isaveterinarian, with meat practitioner inthe and EFSA in2007, worked he asa Contaminants Before Unit. joining Biological Hazards and team acting and leader atEFSA’s Pietro Stella isascientificofficer ,University ofGuelph

DAY 2 • 19 September 47 Advancing risk science assessment -Biologicalhazards Alessandra Carattoli do we know, we whatshould out? find foodbornecausing humaninfections: what Molecular epidemiologyofAMRinbacteria conflicted (ECW,relationship withinsects. 2017). 2013); Eat and Beetles!anexploration the into our evolution, ecology asustainablesociety and (ECW, OriginThe ofFeces: whatexcrement tells usabout foodborne diseases. recent Hismost books were naturalthe cultural and history ofzoonoses and mystery, four and books ofpopularscience on stories, acollectionmonologues, ofshort amurder of poetry, acollection ofrecipes dramatic and bookchapters,and sixbooks haspublished he moreand than100peer-reviewed scholarly papers oftextbooks orco-author anauthor Besides being M. (CABI, 2015). Waltner-ToewsSchelling E, D, Whittaker M,Tanner Practiceand ofIntegrated Health, J, edsZinsstag wrote several chapters Health: inOne Theory The Francis/CRC Press, 2008). Heco-edited co- and Margaret Gitauand (with Thomas Gitau,Taylor and of Health Sustainability and ofAgroecosytems University Press, 2008), Integrated and Assessment (with Nina-Marie Lister Kay, James and Columbia Uncertainty, for Managing and Sustainability Press, 2004), Ecosystem The Approach: Complexity, Health: APractical Approach (Cambridge University His textbooks include Ecosystem Sustainability and International Development Research Centre. that celebrated anniversary ofCanada’s 40th the year was he aspeaker ‘Speakers inthe ofRenown’ series contributions to ecosystem approaches to health; same presented inaugural himwiththe award for Internationalthe Association for Ecology Health and Frontières –Canada. In2010, inLondon, England, of resistance determinants inbacteria ofclinical onknowledgeimpacting ofhorizontal transmission concept the lastdecade the ofbacterial typing, has identification ofplasmids, and changed over adopted world-wide for invitro insilico and PlasmidFinder have database. methods These been Typing, plasmidMLST ofthe author the and typing, inventor the being ofPCR-Based Replicon recognised expert onplasmididentification and Scholar April 2018), aninternationally and papers listedof 148 in PubMed, H-index = 57 (Google Universitythe ofBern inSwitzerland. isauthor She Professor Institute atthe ofInfectious Diseases of Director. From 2013 to 2015, was she visiting EFSA JOURNAL |SUPPLEMENT of Rome, currentlyof Rome, asResearch Istitutoat the Superiore diSanità permanent ofthe member staff Since 1997 hasbeena she University Sapienza’. ‘La ofRome Faculty ofthe ofMedicine Cellular Biologyin1989atthe a PhDdegree inMolecular and Dr Alessandra Carattoli received ,NationalInstitute ofHealth producing animals:anEUperspective of epidemiology, infood orAmpCβ-lactamases β-lactamases andfood- of enterobacterial isolates producing extended-spectrum K, Torren-Edo J, Torres Threlfall C, J. 2013. Publichealth risks Mevius D, Peixe Schuepbach-Regula Poirel Torneke G, L, L, CarattoliLiebana E, Coque TM,HasmanH, Magiorakos A, AP, References that causefoodborne human infections. circulation colistin ofmobile resistance inbacteria the humansand animalsand in bacteria from of extended-spectrum (ESBLs) beta-lactamases routeabout the oftransmission dissemination and farm clues Dataalsosuggestsome clinic. the and two-waythe traffic ofAMR bacteria between the isrevealingsequencing to beginning and quantify features between two the sources. genome Whole appear usefulto trace spread the ofcommon AMR between food-producing humans, animalsand of plasmid-mediated transmission ofAMRgenes humaninfections.causing However, dynamics the harbourdid not strains clonally related to those beef, pork food other and products samples from human clinical cases.Inseveral studies,retail meat from determinants alsoidentifiedinstrains used infarm ofresistance selection animalsonthe ofspecificantimicrobial impact about the drugs epidemiologicaldataofferand explanation some a profile (plasmids) elements mobile genetic of analysis ofbacterial combined genomes, with source For ofAMRgenes. example, phylogenetic how food canbeavehicle for AMRbacteria ora approaches to canhelp recognise describe and development The patient. ofnew molecular related their and canarise genes human inthe tohelps clarify routes allthe by which AMRbacteria determinants located elements genetic onmobile different bacterial populationsofresistance ability The needed. to trace circulation the within understanding dynamicsofbacteria ofthe is animals,adetailed,quantitative populations from humansto microbial AMR inbacteria from (AMR) transmission dissemination.To and link of bacteria involved inantimicrobial resistance foodborne humaninfections represent asubset relativelyThe few bacteria speciesthatcause Italiana’ conferred by President the ItalianRepublic. ofthe ‘Commendatore Ordine diMerito dellaRepubblica 2017 received she January On 9th honour the researchers-announced-2017/). (https://publons.com/blog/2017-most-cited- Researcher by Clarivate Web Analytics ofScience; in2017and was Top listofthe inthe 1%HighlyCited (http://hcr.stateofinnovation.thomsonreuters.com/) Pharmacology Toxicology, and Influential ScientificMinds byISI-Thompson Reuters wasShe listed in2015 2016 and World’s inthe Most Microbiology by Hungarian the Academy ofScience. Membership Hungarian ofthe Society of Conference. In2014 was she given Honorary Program Committee ICAAC-Microbe ofthe ASM area, since and 2014 ofthe hasbeenamember she Resistancethe Mechanisms Consequences and ICAACOutstanding Program Committee Award in relevance. haswon She twice (in2011 2013) and the

DAY 2 • 19 September 48 Advancing risk science assessment -Biologicalhazards Thomas U.Thomas Berendonk resistance insurface water water and reuse implicationsfor their and antimicrobial Wastewater treatment planteffluents Key words: Escherichia mcr, plasmids,Salmonella coli, ESBL, London BBiologicalScience, 370(1670), 20140083. environment. PhilosophicalTransactions oftheRoyal Society Antimicrobial resistance inhumans,livestock andthewider Woolhouse, M.,Ward M.,van BunnikB.,J. Farrar J. 2015. Infectious Diseases, 1030–1037. 56, methods,risk factorsanalytical andcontrol options.Clinical effluents to receiving environments (Berendonk organisms are genes and released withWWTP but there isclear evidence thatantibioticresistant in municipal WWTPs hasjustbeganto beexplored, dynamics ofresistant bacteria associated and genes resistant bacteria To genes. their and date, the plants (WWTPs) source asasinkand for antibiotic interested role inthe ofwastewater treatment resistant pathogens, scientists are increasingly Due to worldwide the health of antibiotic impact Universität Dresden inthatcapacity in2008. 2007. Hetook upemployment Technische withthe diversity aFull became ofspecies”)and Professor in processes influence their and genetic onthe (“Analyses ofhistoric recent and ecological Hecompleteduntil 2008. hishabilitationinZoology Leipzig University continued and inthatposition lecturer) Zoological atthe Institute (BiologyII)at tenurewithout track, Australia =departmental Wissenschaftlicher Assistent (USA=assistantProf, to Germany in2003 to take upapositionas Zoology, Oxford University (2002-2003). Hereturned Imperial College of London, Department the and NERC Centre for Population Biology(2000-2002), Museum ofNatural History, London (1999-2000), postdoctoralHe held research positionsatthe doctoral research training United inthe Kingdom. Society. Following undertook thathe 4years post- received Otto the Hahnaward Max-Planck ofthe Institute Plön,Germany hisPhDthesis in1998and Max-Planck- cumlaude” (1.0) from a PhD“magna Universität Dresden since Hegraduated 2008. with positionofFullthe Professor atTechnische Environmental Research (HIGRADE). Hehasheld Interdisciplinary GRADuate School for spokesman for Universities the Helmholtz inthe Centre for Environmental Research (UFZ)) and betweenpartnership TUD Helmholtz the and largest centres for water research, aformal Water Research (CAWR) ofEurope's – (one EFSA JOURNAL |SUPPLEMENT cycle Centre atthe for Advanced quality quantity and water ofthe He isspokesman for water Technische Universität Dresden. Environmental Sciences atthe Hydrobiology Faculty atthe of Director Institute ofthe for Professor and ofLimnology Prof. Dr. Berendonk Thomas is ,Technical University ofDresden reuse Keywords: Wastewater, treatment surface plant, water, water Environments. Environ. Sci.Technol. 50, 11825–11836(2016). Cassettes inWastewater 3. Gatica,J. etal.HighThroughput Analysis ofIntegron Gene (2015). 7183–7186 Pollut. Res.22, inwastewateropportunities REUSe(NEREUS).Environ. Sci. Emerging challenges and Fatta-Kassinos,2. D. etal.COST ActionES1403: New and Rev. Microbiol. 13,310–317(2015). Nat. environmental framework. 1. Berendonk, T. U. etal.Tackling antibioticresistance: the References Jolyon Medlock expect how and well are we prepared? Vector-borne diseases inEurope: whatcanwe ECDC/EFSA-funded VECTORNET inwhich led he has beeninvolved inECDC-funded VBORNET and detection UKsince inthe 2005, since and 2009 he has beeninvolved withtick surveillance and surveillance in>30European countries. Hisgroup aprogrammemanaging for tick enhancing European-wide vector-surveillance programmes, 2009 has alsobeeninvolved he withleading government’s lead onvector-related issues.Since groups for about15years UK isthe and of UKGovernment Health One risk assessment reviewed scientific papers.member Hehasbeena borne diseases, >100peer- haspublished and research ona range ofmosquito-borne tick- and vector surveillance systems coordinating and borne disease Thisinvolves risk. UK-wide managing responsible for UKgovernment advising onvector- He leads MedicalEntomology the group, Protection Agency now and PublicHealth England. hasworkedhe atPorton Down, for Health the lymphaticfilariasisand withthe LSTM. Since 2002, conducting and researchDepartment onmalaria (Fatta-Kassinos etal.2015; Gaticaetal.2016). resistance wastewater when isusedfor irrigation NEREUSfocusingaction fate onthe ofantibiotic I willshow results some ofmy group COST the and resistance context withinthe genes ofwater reuse. implicationsfor discusstheir and spread the of In thispresentation Isummarize results these significant sometimes and reduction even increase. showby no 16SrRNA copy numbers frequently abundances ofkey resistance normalized genes treatment, butitisalsoapparent thatrelative copies are reduced during conventional wastewater absolute quantity ofantibioticresistance gene et al.2015). Studieshave demonstrated thatthe ,PublicHealth England with Oxfam’s Humanitarian control invarious ofAfrica parts spent 4years working onmalaria of Tropical (LSTM), Medicine he Bristol Liverpool the and School Universities ofManchester and years. Having trained atthe on vector-borne diseases for 20 Dr Jolyon Medlock hasworked

DAY 2 • 19 September 49 Advancing risk science assessment -Biologicalhazards borne disease issues. government veterinary onbothpublicand vector- foci ofdisease abetter and importance, informed lead to better publicawareness, discovery ofnew years oftick surveillance, many the and outputsthat encephalitis virus.Finally itwillpresent dataon12 Congo haemorrhagic fever tickborne virusand arboviruses inwestern Europe such asCrimean– as well risk asguiding onemerging assessment of policy change ontick controls ontravelling pets, imported ticks, inrelation to developing evidence ofmonitoring importance it willhighlightthe clinicalongoing virology Onticks, diagnostics. risks, to need the and incorporate vector datainto mosquito surveillance inrelation to West Nilevirus ofroutine importance will highlightthe native transmission ofZika chikungunya and virus.It of invasive mosquitoes concerns and over local will beillustrated by examples surveillance onthe to prevent control and any emerging disease. This ministersthe to and bebetter public, and placed empirical evidence to bewell informed, bothfor ensureimplications and thatgovernment hasthe to better inform mitigate risk, the any disease enhanced targeted surveillance research and surveillance thatrequire triggers alerts further ofnon-native importance the species.Routine emergencethe ofnew vector-related issuesand to detect respond and to changes indistribution, for need highlight the vector ongoing surveillance entomologist’sa medical perspective. Itwill risk onvector-borne assessment diseases from >15years ofcontributing tofrom government first step. This paper willdetail experiences relativetheir roles intransmission isanimportant knowledgearthropods) vector arthropod ofthe and For vector-borne diseases transmitted (those by successful control proportionate and response. of disease ecology epidemiologyhinders and aresponse.mounting Failure to consider allaspects approach isparamount for risk for and assessment humans)thismultidisciplinary animals and wildlife zoonoses (pathogens transferred between wildlife disease. As alarge ofEIDsare proportion expert inbacteriology, virology, entomology and veterinaryexperts inhumanand health, aswell as Health aOne using approach, bringing together Emerging infectious are diseases now (EID) tackled to UK’s Overseas Territories Hurricane Irma. from control ofZika vectors, including rapid deployment Caribbeanin the inrelation to surveillance and has alsorecently to ledUKsupport seven countries He than 30countries inEurope Africa. North and capacity training building, surveillance and inmore tickthe Thisinvolved consortium. supporting EFSA JOURNAL |SUPPLEMENT Peter Gerner-Smidt investigation opportunities and –Challenges foodborne disease surveillance outbreak and Next generation asatool sequencing in and Prevention genome orcoregenome multi-locus genome sequence polymorphisms (SNPs)whileothers usewhole Why laboratories dosome nucleotide usesingle than others; tend some to produce specificerrors. globally. NGSplatforms Some are more accurate in different laboratories nationally, regionally and challenge comparing when WGS datagenerated upon standards for sequence quality. Thisposesa results there and are internationally no agreed provide donot exactly(‘pipelines’) same the different NGSplatforms applications analytical and workflow. However, sequences generated on microbiological workflows efficientNGS withone replacing amultitude ofdifferent traditional virulence antimicrobial and resistance profiles, pathogens like species,serotype, comprehensive WGS isalsousedto predict characteristics ofthe faster keep and smaller. them information The from to detect, investigate control and more outbreaks of transmission. BecauseofWGS, itisnow possible detailed knowledge routes onpathogens their and withhitherto unheard industry and academia of (WGS) ofamicroorganism, providing authorities, way to determine sequence genome whole the (NGS)hasemergedsequencing asacost-efficient prevent next lastdecade, Inthe them. generation infections isessentialinorder to control and determiningand majorsources the ofhuman component to detect investigate and outbreaks throughoutand food production isacritical people comparing pathogens isolated from efficiently control problem. the Monitoring and food production publichealth and to isneeded approach whole the involving stakeholders from becomes ill.Outbreaks are common. Health AOne in adifferent continent thanwhere patient the any borders: source the ofaninfection may be feed, foodborne infections respect longer no globalisationand oftrade ofanimals,food and With ever-increasing international travel by people Foodborne are illnesses common butpreventable. International. Global Microbial Identifierinitiative PulseNet and involved globally initsimplementation through the United inthe CDCand at the States. Heisalso health surveillance ofbacterial foodborne infections for sequencing genome whole implement public in Atlanta, United States. Heisleading to effort the Disease Control Prevention and Diseases Centers atthe for Waterborne Environmental and Divisionforthe Foodborne, Diseases Laboratory Branch in chiefHe isthe Enteric ofthe specialty inclinical microbiology. Danish/American MD, DScwith Dr Peter Gerner-Smidt isa ,Center for DiseasesControl

DAY 2 • 19 September 50 Advancing risk science assessment -Biologicalhazards Authority Ernesto Liebana Criado Nikolaus Kriz PANELLISTS ensure correct decisionmaking infood safety datainany given supporting other context to data willalways to need beinterpreted with along finally,And be itshould remembered that WGS comparisons ofdatagenerated inany laboratory. platforms workflows and to ensureaccurate WGS analysis validating and different sequencing work towards creating international standards for PulseNet International together withitspartners WGS? To avoid having to consider issues, these decision makers to need know aboutNGSand reliable accurate? and How much dofood safety profile antimicrobial and resistance, equally phenotypic characteristics, e.g. serotype, virulence genotypic usedto pipelines predict same the typing (wg/cgMLST) for subtyping? Are the He isafellow Royal ofthe College ofPathologists. veterinary surgeon, aPhDinmicrobiology. holds and Veterinary Laboratories Agency. Hegraduated asa Food Environmental and Safety, Pathology and inthe Agriculture of Ireland), Northern Departments the and Veterinary of Sciences Division(Department Complutenseat the University ofMadrid, the researcher area inthe ofzoonoses publichealth and of biologicalhazards. was he Before EFSA, joining Medicine. University the ofVeterinarySydney aPhDfrom and University the of veterinary clinical studiesfrom is aveterinary surgeon, aMaster’s holding degree in emphasis onvaccines innovative and products. He diseases veterinary and withaparticular medicines EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority assessment activities in the area inthe activities assessment scientific coordination of risk has beendedicated to the senior scientificofficer,where he In 2007, EFSA joined he asa Hazards Contaminants and Unit. headacting ofEFSA’s Biological scientific officer, team and leader Ernesto Liebana isasenior safety area mainlyininfectious animalhealthboth the food and worked inregulatory bodiesin clinics has and academia, and general practice, specialised experience onfour continents in Nik has25years ofprofessional PlantHealthAnimal and Unit. Nikolaus Kriz ishead ofEFSA’s ,European Food Safety

DAY 2 • 19 September 51 Advancing risk science assessment -Humanhealth (continued) Human health (continued) Advancing riskassessmentscience will be discussed. will bediscussed. New tools thatmay facilitate thistransition challenges thataparadigm shiftmay entail. be addressed holistically, accounting for the risk and assessment characterisation) will paradigm (hazard characterisation, exposure traditional ofthe usefulness risk assessment human health The risk assessment. unresolved challenges, for needs and This sessionwillhighlightrelevant advances, reduction ofanimaltesting. health risk aswell assessments asthe promising for improvement the ofhuman developments These pathogenesis. the are toalone provision the ofinformation on empirical observations transition from epidemiological research isfacing a testingnon-animal Moreover, models. responses. tools Mostofthese willbe more accurate predictions ofbiological adverse effects level, molecular atthe and that enableabetter understanding of Newassessments. tools are emerging usedtoand advance further risk epidemiologycouldand beintegrated advances intoxicology, exposure science how latest the scientificand technological considerations recommendations and on thatprovides areport published Engineering, recently Medicine and NationalAcademiesThe ofSciences, EFSA JOURNAL |SUPPLEMENT Heather Wallace Angelika Tritscher CHAIRS Barry DelclosBarry A(BPA)of bisphenol inrats chronicand extended study dose-range CLARITY-BPA core aperinatal study: SPEAKERS adversely affects human health, including active during particularly agents, development, hypothesis thatexposure to low levels ofhormonally Toxicology Program to evaluate ofthe aspects Agreement between FDA the National the and studies conducted anInteragency under He hasserved asPrincipal Investigator onaseries of oftoxicity modulation and agents by factors. dietary ,USFood &DrugAdministration ,University ofAberdeen Seebiography p.27 Seebiography p.27 associated withendocrine active have focused ontoxicities recent years, hisresearch efforts In Jefferson, Arkansas, USA. Toxicological Research in FDA’s NationalCenter for Biochemical Toxicology atthe Pharmacologist Divisionof inthe DelclosBarry isaResearch ,World Health Organisation

DAY 3 • 20 September 52 Advancing risk science assessment -Humanhealth (continued) In the lateIn the study(weeks ofthe stages 96–104),mean data collected interim atthe sacrifice sex. ineither treatment in-life the among ornon-histopathology noted. There were few significant effects ofBPA at 2years parsin the pituitary distalisofthe was fewhad effects inmales;anincrease inhyperplasia combined adenomas/carcinomas. pituitary and EE2 adenocarcinomas gland incidence ofmammary there was astatisticallysignificantincrease inthe interim terminal and sacrifices. At terminal sacrifice, in female reproductive organs, were increased at sacrifice lesions, non-neoplastic particularly and Multiple organ weights were affected interim atthe exhibited prolonged oestrusby 16weeks ofage. More animals inthisgroup than90%ofthe bw/day doseelicited strong responses infemales. interim terminal and sacrifices). The 0.5 μgEE2/kg (interim sacrifice histopathology only),and (both parameters (interim sacrifice only),organ weights clinical (interim chemistry sacrifice only),sperm onsetofaberrant ofthe an assessment cycles, atvaginalage vaginal opening, cytology, including included survival, bodyweights, litter parameters, groups were analysed separately. Datacollected study arm, sacrifice and BPA and time EE2 and Statistical comparisons were conducted withinsex, terminated at1year (interim) 2years and (terminal). early exposure. Inboth studyarms, animalswere termination, to assessany effects thatwere dueto treatmentday further without held 21 then and until BPA dosesonly, withanimalsdoseduntilpostnatal arm), studyarm astop-dose was included for the dosed dailythroughout study(continuous-dose the carboxymethylcellulose. to Inaddition animals to model the anoestrogen. vehicle The was 0.3% were alsoincluded to monitor response the of 0.5and μg/kg bw/day) ofethinyl estradiol (EE2) oestrogen pathways, signalling two doses(0.05 reportedthe effects ofBPA are associated with μg/kg bodyweight (bw)/day). Becausemany of margin ofexposure 25,250, (2.5, 2,500, 25,000 and estimated humanexposure levels to areasonable asclose asfeasible towas usedranging from levels throughout. Awiderange ofBPA doses materials were monitored for background BPA was examined inSprague-Dawley rats. Study postnataldayto 1 pupsby dailygavage from day directly then oflabourand 6through start the BPA administered gestation by oral gavage from compliant core studies.Inthe study, toxicity the of typically not endpoints assessedinguideline- a range ofmolecular, structural functional and tissues to groups 14academic for of assessment chronic rat studythatalsoprovided animalsand consisted ofacore guideline-compliant modified onBPAuncertainties toxicity. programme The Administration to attempt to address scientific Health Sciences USFood the and Drug and between NationalInstitute the ofEnvironmental conducted anInteragency under Agreement CLARITY-BPAThe research programme was conducted by FDA regulatory other and agencies. provideand dataofutility insafety assessments studies have to beendesigned address datagaps reproductive carcinogenesis. and function These EFSA JOURNAL |SUPPLEMENT often occurred low inonlyasingle ormiddledose study, lack the ofdose-response, fact the thatthey statistically significantBPA effects observed inthis at 25,000 μgBPA/kg bw/day. For ofthe most increase inlymphocyte infiltration epididymis inthe was anincrease inexfoliated germ cells an and terminalin continuous-dose sacrifice males,there interimcontinuous-dose sacrificenot males,but BPA/kg bw/day animals.In continuous-dose inthe statistically significanteffect 25μg alsoseenatthe at 25,000 μgBPA/kg bw/day was noted, witha of hyperplasia pars inthe pituitary distalisofthe stop- males,anincrease continuous-dose and or terminal sacrifice males.In terminal sacrifice effects in BPA interim orcontinuous-dose stop-dose levels. There were treatment-related no neoplastic with asimilarresponse across each dose ofthose 25to 25,000 μgBPA/kgat dosesfrom bw/day, increased interminal BPA continuous-dose animals bw/day. Vaginal hyperplasia epithelial was also hyperplasia were elevated at25,000 μg BPA/kg endometriumof the vaginal and epithelial interim females, apoptosis luminalepithelium ofthe terminal animals.Incontinuous-dose stop-dose noted 25,000 and at2,500 μgBPA/kg bw/day inthe An increase incystic endometrial hyperplasia was bw/day interim instop-dose sacrifice BPA animals. in follicular cysts ovary inthe at25,000 μgBPA/kg was anincreased trend significantincrease and lesionsinfemales, non-neoplastic the Among there was terminal observed inthe not sacrifice animals. continuousanimals inthe BPA dosearm, butthis polyps was interim alsoobserved inthe sacrifice kg bw/day. Asignificanttrend for uterine stromal atypical gland female µgBPA/ foci mammary at2.5 continuousthe arm, dosing there was anincrease in or terminal sacrifice BPA stop-dose groups, whilein ofinterim gland mammary lesionsinthe neoplastic There were significanttreatment-related no non- laboratory control whilethe incidences were lower. earlier studiesconducted rats withthese inthis arm treated group were above observed in those dose arm. elevated The incidences stop-dose inthe wasneoplasms continuous observed inthe BPA dose group. Noincrease gland infemale mammary (24% versus 8%) µgBPA/kg 2.5 onlyinthe bw/day combination adenocarcinoma and ofadenoma adenocarcinomagland versus (22% 6%) orthe increase incidence inthe offemale mammary terminal sacrifice, there was astatisticallysignificant treatment BPA stop-dose Inthe effect. studyarm at biologicalplausibility studyonthe the ofatrue interpreted considering allavailable evidence from applied to histopathology the results dataand were analyses to designed minimisefalse negatives were across control BPA and treatment levels. Statistical femalesand were observed thatwere variable inthisstrainwith ageing ofrats inbothmales lesionsassociated non-neoplastic and neoplastic adverse. histopathological Inthe evaluations, were considered not and ofsmallmagnitude few statisticallysignificanteffects inBPA groups clinical ororgan endpoints chemistry weights, the meanthan the vehicle control bodyweights. For groupcontinuous-dose were significantlyhigher female bodyweights 250μgBPA/kg inthe bw/day

DAY 3 • 20 September 53 Advancing risk science assessment -Humanhealth (continued) Health Sciences Nigel Walker CLARITY-BPA the learned from initiative by USNationalToxicology the Program. Lessons investigations inhazard assessments Integrating regulatory academic and range, asbiologicallymeaningful treatment effects. lower inthe effects,establish the particularly dose study arms across and itdifficult made endpoints to responses stop- withinthe continuous-dose and group, lack the and ofaclear pattern ofconsistent Food Drug Administration and (FDA), ofthe one health US beenstudied.The thathad endpoints exposure concern’ levels ‘minimal and for other infetuses,gland infants, children and at current BPA’s effects brain, onthe behaviour, prostate and NTPconcludedThe there was concern’ ‘some for BPA onhumandevelopment reproduction. and scientific literature possibleeffects aboutthe of Toxicology Program (NTP) evaluated available the levels ofBPA urine. intheir National the In2008, of Americans 6years olderhaving and detectable Human exposure to BPA iswidespread, with93% food cans,bottle tops water and supplypipes. used aslacquers to coat products metal such as polycarbonate epoxy plasticsand resins, that are quantities for use primarily production inthe of debate. BPA isachemical produced inlarge A(BPA)bisphenol hasbeenatopic ofconsiderable healthThe oflow-level impact exposure to Liverpool, UK. University the of from his PhDinBiochemistry University the ofBath,UKand from Biochemistry biology. molecular and Hereceived hisBScin developing tools applying and ofmodern toxicology to evaluate ofpublichealth agents concern by government interagency program missionis whose scientificgoalsthe NTP, ofthe aUS Federal to necessary out ofactivities implementation carry formulation,in the coordination and role asDeputy Director for Research isinvolved he of compounds studiedby NTP. the Inhiscurrent reviewed toxicity onthe reports carcinogenicity and 140 peer-reviewed publications,including 60peer DrWalker supplements. botanical dietary hasover mixtures, dioxins, persistent organic pollutants,and materials, occupational environmental and investigation by NTPincluding the nanoscale toxicity carcinogenicity and ofcompounds under numerous initiatives understanding potential the over 20 years during and hasworked thistime on EFSA JOURNAL |SUPPLEMENT ,NationalInstitute ofEnvironmental Walker NIEHSfor hasbeenatthe Institutes Dr ofHealth (NIH),USA. ofNational (NIEHS), one Environmental Health Sciences National Institute of Toxicology Program (NTP) atthe National Division ofthe Director for Research for the Dr NigelWalker Deputy isthe peer review procedures such thatguidance was Unitedthe States National Institutes ofHealth (NIH) ofgranteeselection proposals followed traditional resources. Thirdly scheme the for peerreview and required coordination, additional training and sample preparation procedures oranimalhandling centralised coordinated and sohighlyspecialised proposed.endpoints Sample acquisition was that may have not beenoptimalfor specific the limited to aspecificshared using model designand to thisapproach. Academic investigators were dataacquisition.end-point There were limitations subsequent publicaccess to biasin no datahad alsoensured depositionofdataand blinded that This allowed for confidentialacquisition data and workspace NTP’s inthe database before decoding. requirement thatalldatabedeposited inaprivate toof endpoints becollected the perstudyand development (3)the bias; and ofanapriori list grantees, potential the minimising and risk of corethe studysamplesreceived by academic the provided facility same atthe (NCTR); of (2)blinding both components which consortium, ofthe were identicalBPA the (1) exposure conditions usedfor strengths approach, ofthisconsortium included; identical conditions core asthe GLPstudy. key The born to pregnant same the rats exposed and under researchers animals institutionsusing atacademic health conducted endpoints, by NIEHS-funded (2)CLARITY-BPAand grantee studiesofvarious or chronic BPA exposure, including perinatal); Practice (GLP) regulations (2-year perinatal only (NCTR) according to FDA GoodLaboratory FDA’s NationalCenter for Toxicological Research chronicguideline-compliant studyconducted at programme hastwo A‘core’ components: (1) toxicityon the ofBPA. CLARITY-BPA The research research withhypothesis-based research projects was to attempt to bridge guideline-compliant BPA). CLARITY-BPA aimofthe The program Regulatoryand InsightsonBPA Toxicity (CLARITY- programme calledConsortium Linking Academic NTP,NIEHS, FDA the and developed aresearch BPA thatcould inform regulatory decisionmaking, exposurerange ofpotential to health effects from address studyabroader issuesand ofthese some outcome, transparency. datareporting and To bias, directness measures ofend-point to ahealth of studydetails,selective ofdata,risk reporting of chemicalconduct, purity, statisticalpower, reporting often related to exposure levels, studydesignand to integrate different datastreams. issuesare These conducted reported and isachallenge trying when way inwhich different these types ofstudiesare foragencies making risk decisions.The assessment according to for guidelines submissionto regulatory Laboratory Practice (GLP) studiesconducted investigative Good studieswiththose academic reviews integration hasbeenthe ofdatafrom challengesof the through and assessments these review itsongoing and ofscientific evidence. One based onFDA’s recent most safety assessment, containers packaging. and conclusions These are currentlysupports approved usesofBPA infood safe current atthe levels occurring infoods and core NTP, ofthe agencies maintainsthatBPA is

DAY 3 • 20 September 54 Advancing risk science assessment -Humanhealth (continued) Alfonso Lampen as anexample modern chemical risk –3-MCPD assessment potentialThe oftoxicogenomics impact on Thorhallur IHalldorsson health-based guidance value Use ofepidemiologicalstudiesfor setting a collaborative programmes, whiledecreasing costs. their would studies and the utility maximisethe ofsuch of identified regulatory design the datagapsand This would result incloser between alignment the scientistscanprovide. academic whatthe and regulatorythe to scientistsneed make decisions phase more direct communication between what problem formulation development consortia and withmuchis needed more targeted integrated and future initiatives alessresource intensive approach CLARITY-BPA the learned from program isthatfor research questions.Looking forward, akey lesson regulatory butrather needs, hypothesis generated were specificallyaligned not addressto specific more general innature submitted and proposals nutrition studies. for new effect exposition and marker human using ofeffectestablishment directed analysis, search and gastrointestinal barrier toxicogenomics, using mechanism ofdetoxification/toxificationthe in questions inrisk such assessment molecular asthe safety. Majorresearch are activities focused onopen internationalnational and expert groups infood gastrointestinalthe barrier. ofseveral Heismember investigation for inparticularly studiesregarding development ofnew invitro for methods food safety internationally awarded several e.g. times for the international journals. Hewas nationallyand of many peerreviewed papers inhighlyranked grants BMBF, (DFG, EU).Professor isauthor Lampen EFSA JOURNAL |SUPPLEMENT ,Federal Institute for RiskAssessment several international nationaland Germany. Hehasmanaged of Veterinary Hannover, Medicine Food Toxicology University atthe (BfR). Heisanextra Professor for Institute for RiskAssessment Food Safety Federal atthe of Headthe Department ofthe Professor DrAlfonso is Lampen See biography p.29 ,University ofIceland QSAR, risk assessment Keywords: MCPD, moleculardocking, ’omics, PBPK modelling, will fundamentally improvewill fundamentally future. RAinthe ’omics data,together biomarkers, withendogenic (e.g.methods QSAR,PBPK aswell modelling) as new techniquesIn summary such asinsilico data,biomarker(metabolomics ofexposure). (AOP endpoints data)withhumanendogenic vitro ’omics datatogether withbiologicalendpoints exposure concept by comparing relevant humanin it may bepossible to modulate margin the of adverse outcomes withsignificant evidence. Then, develop appropriate invitro test systems to predict near future. Furthermore, itwillalsobepossibleto observed by ’omics to methods adversity inthe AOP concept, itwillbepossibleto linkMOA effects by ofrelevant implementation MOA datainto the effects, becauseofexisting limitations.However, standard toxicity tests performed to adverse identify has beenonlylimited useof’omics techniques in be usedinRAfor determining Sofar, there MOA. RAof3-MCPD,the showing that’omics datacould were recently taken upby EFSA course inthe of this relevant food new These contaminant. results new insightsinto (MOA) ofaction mode the of proteinat the level inkidney, liver, testis, and giving antioxidant protein DJ-1 was strongly deregulated to glucose oxidative utilisationand stress. The recovered targets molecular of3-MCPD, e.g. related transcriptomeand of3-MCPD-treated rats identified. Ourdetailedanalysis proteome ofthe approach, 3-monochloropropanediol was (3-MCPD) apriorityestablished listofcompounds. Inthis heat-induced processing contaminants and carcinogenic chemicals more among than800 (QSAR), we could differentiate and mutagenic insilico Byusing future methods role inRA. way pointsthe RA and forward for possible their demonstrated how ’omics datamay beusedin From food toxicology examples, itwillbe characterisation ofchemicals. may integration bethe of’omics datainto risk the relationships. Therefore, goal one future inthe of relevant quantitative dataondose–response significant in risk characterisation due lackto the significant role inhazard not identification,but (RA), however, onlyplay methods these a to regulatory toxicology. Inrisk assessments by OECD, WHO others and to way bethe forward adverse to effects, molecular hasbeenproposed pathway concept (AOP), which tries to link past Currently, decade. adverse the outcome substantially intoxicological research over the respectively,(metabolomics), have beenestablished proteomethe (proteomics) metabolome the and transcriptome the (genomics), (transcriptomics), addressingOmics methods genome whole the

DAY 3 • 20 September 55 Advancing risk science assessment -Humanhealth (continued) Environmental andOccupational Health &Safety Christophe Rousselle consumers related to exposure cadmium for workers and toolsUse ofmodelisation to assessrisks creatinine to not of age) asafunction beexceeded Cdlimit urinary concentration (Cd HBGVinμg/g of itpossibletoalso made estimate change the inthe intake (TWI) of2.45 µg/kg bw/w]. PBPK The model was derived [corresponding to atolerable weekly a tolerable daily intake (TDI) of0.35 µgCd/kg bw/day concentration values withCd oral exposition values, body weight thatlinks and age, and Cd urinary variation ofcreatinine excretion according to Based onaPBPK including model dataonthe population over 60years ofage]. observed-adverse-effect level (NOAEL) value for a is 0.5 µgofCd/g creatinine [considered asano- al. askey critical studies.The internal dosechosen byepidemiological studiespublished Engström et to beusedto derive TRV. the experts adopted The effectsANSES hasidentifiedbone asthe key effects reviewing effects the ofCd onhumanhealth, value (TRV) for Cd, viaoral chronic exposure. After ANSES willpropose anew toxicological reference consumed by humans. subsequent contamination ofplantproductions (MFSC), to control agricultural the soilpollutionand levels materials infertilising culture and media ofCdingestion onaproposal and for Cd maximum at revising itstoxicological reference value (TRV) for At request the ofvarious ministries, ANSESworked recognised toxicity for humans. thereby entering food the chain exerting and its roots,their alsoby orsometimes aerial their parts, general populationasitenters plantsgenerally by main source ofCd exposure for non-smoking the of great concern. Foodstuffs are considered the transfer, making Cd afood-chain contaminant toxicant thatexhibits highrates ofsoil-to-plant Cadmium (Cd) isahighlypersistent environmental Consumer Safety 2009. European atthe level from Scientific been anexpert onthe Committee for alsowithReachand regulation CLP. and Hehasalso Unit dealing withchemicals inconsumer products currently head the RiskAssessment Chemical ofthe Occupationaland Health Safety and (ANSES).Heis now French atthe Agency for Food, Environment Occupationaland Health Safety and (AFSSET) and French atthe then and Agency for Environment first in the French Agency (AFSSAPS)for Medicines EFSA JOURNAL |SUPPLEMENT 15 years inregulatory toxicology, has beenworking for more than (2016). Rennes He Health from International Master inPublic (2000) more and recently an PhD inToxicology Paris from Lyon. was Hethen awarded a Veterinary the from School of Christophe Roussellegraduated ,French Agency for Food, two stages: constructionThe was model ofthe carried outin resulting inamajorsupplyofCd food inthe chain. scenarios materials, viafertiliser ofsoilfertilisation consumers, together useofvarious withthe major food contributors to Cd exposure ofFrench potatoes,and two origin plantsidentifiedasthe of focusedassessment more onwheat particularly persistence behaviour ofCd) was elaborated. The soils over aprojection of99years time (dueto the inputofCd the in human consumption from of contamination ofCd inplantsintended for A predictive for model development the estimating creatinine inadulthood). to avoid exceeding internal the TRV(0.5 μg/g percentage ofexcess TRV. ofthe scenarios. Itisalsofeasible to apossible identify crops (wheat grain potato) and linked to fertilisation with studyofdevelopment ofCd contamination in (10, model 20,of the 60, 99years), incorrelation 95th percentile, projection ofthe asafunction time child average consumer’s chronic exposure and allow model data ofthe derivation adult ofthe and final inthe and related food products. output The predictive to support estimate Cd levels inplants So, elaborated the based model onCd fluxisa • • consumer Cd exposure. plants allowed to then estimate on impact the variationsobtained Cd ofthe concentration in or increase) wheat inthe grain potatoes. and The Cdobtain the concentration variations (reduction updated runwiththe then to ANSESmodel Simulations ofvarious scenarios fertilisation were to evaluate exposure dietary the associated. in foodstuffs. hasbeenupdated Thismodel revisionthe ofmaximumlevels ofcadmium referral of the aspart ANSES, 2011-SA-0194 on based onanexisting implemented model by exposure. was model ofthe Thissecond part tomodelled, estimate onconsumer impact the production to consumers the through food was In asecond step, plant the transfer the ofCd from years. agricultural practice over aprojection of99 time materials inputsviafertiliser cadmium their and crops aswell Cd asthe leached, of asafunction of agricultural Cd soils,the contamination of makes itpossibleto Cd studythe contamination thistransfer.along Thisfirstmodel phaseofthe variabilities; also(4) and French specificities soil(food the crops, leaching);release (3) from deposition, irrigation water); (2)routes ofCd agricultural materials, soil(fertilising atmospheric into account: routes allthe (1) ofCd into entry the approach, basisthe ofa‘mass-balance’ taking was model ofthe Thispart modelled. built on production (potato wheat and grain) was onagriculturalfertilisers soilsto plant the Firstly, itsinputvia transfer the ofCd from

DAY 3 • 20 September 56 withsocietyEngaging Engaging withsocietyEngaging scientific uncertainties. scientific uncertainties. risk governance incommunicating and widerangethe ofsocietalconcerns in challenges associated withconsidering latestthe developments field;and inthe a meaningful manner, accounting for couldthis engagement beachieved in science decision-making; and whether inregulatoryof societalengagement This sessionwilladdress: relevance the of anexpert-informed assessment. audiences legitimacy ofthe authority and information, attempting to convince of values asaone-way process to deliver focused oncommunicating facts instead So far, risk communication hastypically policy-makingdecision- and process. legitimacy sustainability and ofthe contribute to improving quality, the society aboutsocietalissuescould Moving towards deliberatively engaging values inanopentwo-way dialogue. making by addressing bothfacts and could lead to better trusted risk decision- ofscienceas amode communication that hasbeenproposedSocietal engagement Public trustinrisk governance iswaning. EFSA JOURNAL |SUPPLEMENT Ellen Vos Barbara Gallani CHAIR Mendes J, 2011. Participationandthe role ofthelaw after Lisbon: References of engagement withstakeholdersof engagement citizens. and researchand institutions.Itwilldiscuss various models inscienceEU institutions,and making by EUagencies citizensassociations) and indecisionmaking by the involvement ofstakeholders (including representative requirementswill discussthe possibilitiesfor and equal treatment Thispresentation ofparticipants. ofproblem-solvingindependently aswell needs as toneeds bereconsidered soasto ensure voice representative publicatlarge the associationsand relationshipthat the between EUinstitutionsand procedures means ofjustificationdecisions.It and EUinstitutions,inaccesswith the to decision-making as strengthening relationship positionintheir their representative and individuals associations,aswell beconsidered should participation voice asgiving to foundations ofdemocracy EU. inthe Thisrequires that TEU, we cansay today ofthe isone thatparticipation founding legalprinciple. Hence, 11 based onArticle TreatyThe ofLisbonhaselevated asa participation Master areas. inthese PhDtheses and numerous areas. hassupervised) (and supervises She nanotechnology). extensively haspublished She in these principle,(precautionary food safety, pharmaceuticals, market agencies), and integration EUrisk and regulation areas ofinterest are EUlaw governance and (comitology European University Institute inFlorence. Ellen’s main ,Maastricht University ,European Food Safety Authority obtained her PhD in Law at the PhDinLaw her obtained atthe Maastricht wrote (CERiM).She and for European Research in University Centre the (MCEL)and for European Law ofMaastricht co-director Maastricht ofthe Centre Maastricht University. is She EU law Law atthe Faculty of Professor Dr EllenVos isprofessor of Seebiography p.7

DAY 3 • 20 September 57 withsocietyEngaging and Prevention Junshi Chen Cissi Askwall stakeholdersparticipation, Key words: EUagencies,decisionmaking, citizens, publications/2018/eu-agencies-on-the-move-challenges-ahead/ Available 1/2018. SIEPS, online:http://www.sieps.se/en/ Vos, (2018), EUagenciesonthemove: E. challenges ahead, the EU. Oxford University Press, Oxford. pp. 206–228. Independence andLegitimacy intheInstitutionalSystem of Vos EUagenciesandIndependence. 2016. In:DRitleng(ed.), E, a legalview 11 TEU, Common onArticle 48 MarketRev. L. 1849. Chinese National ExpertChinese Committee for Food Safety Recently, was he appointed Chairofthe as the Prevention ofCancer: aGlobal Perspective’ (1997). WCRF/AICRthe ‘Food, report Nutrition the and expert panel wrote ofthe who member He isthe laboratory humanintervention studyand trials. protectiveon the effects oftea oncancer, including From late conducted 1980s,he aseries ofstudies Prof. Richard Peto, University ofOxford since 1983. with DrT. Colin Campbell, Cornell University and nutrition chronic and diet, diseases, incollaboration He hasconducted large epidemiologicalstudieson China NationalCenter for Food Safety RiskAssessment. positionofSeniorResearchthe Professor atthe Preventive Since Beijing. Medicine), 2011, hashad he Europeanthe Science Association, Engagement EUSEA. groups Vice and advisory expert and President of ofseveral isamember She portal. international responsibility for proposed the implementing web more accessible, following which was she given into how to make digitaliseand Swedish cultural life Principal ofagovernmental Secretary investigation Engineering Sciences. Furthermore, was she the at VA Royal atthe and Swedish Academy of TT. Head hasalsobeenthe She ofCommunications broadcaster, aswell nationalnews asatthe agency at Swedish Radio, nationalpublicservice the worked previously asanews journalist producer and EFSA JOURNAL |SUPPLEMENT

, ,ChineseCenter for DiseaseControl

European Science EngagementAssociation (the former(the Academy Chinese of Disease Control Prevention and Food Safety, Center Chinese for Instituteat the ofNutrition and research for more than50years nutrition food and safety in hasbeenengaged and MedicalCollegeBeijing in1956 graduatedDr JunshiChen from psychology theology. and She has alsostudiedpoliticalscience, University ofGothenburg and the diploma inJournalism from Science) since 2011. hasa She VA Allmänhet, and (Publicand non-profit association Vetenskap GeneralSecretary Swedish ofthe Cissi Askwall hasbeenthe Giulia Nicolini RAPPORTEURS Anthony Smith Lucia Parrino processes. community development participatory and communication,and focusing on particularly working intersection atthe between socialresearch London. University SOAS, of anthropology offood from Foundation. aMaster’s Giuliaholds degree in Total DietStudyinChina. chronicand diseases; food the and fortification; toxicology; nutrition epidemiologicalstudiesondiet, risk risk and assessment communication; food risk following inthe assessment areas: food safety epidemiology aswell asfood safety surveillance and Dr Chen’s research interests focus onnutrition Life Sciences Institute) Focal Point inChina. Safety Expert Panel Director and ofILSI (International Coordination Group (IACG), WHO ofthe member Food (2007–2017), UNco-convener AMRInter-Agency ofthe Codexthe Committee onFood Additives (CCFA) Internationally, chairperson serves asthe he of Food Safety Standard Reviewing Committee. Risk Assessment Vice-Chair the and National ofthe ,European Food Safety Authority ,European Food Safety Authority ,European Food Safety Authority at Chatham House and the Food the at ChathamHouseand previously completed internships communications She activities. to socialscience internal and Her mainresponsibilities relate Cooperationand Department. Communication, Engagement trainee atEFSA’s Giulia Nicolini iscurrently a uncertainty inscientific EFSA oncommunication of isinvolvedwho inresearch at communications professional Heisa Department. Cooperation and Engagement at EFSA’s Communication, Anthony Smithcurrently works a practitioner, hasbeen she Milano. Bothasaresearcher and Politecnico di design from in communication service and sociology,and aPhD holds and has abackground ineconomics eventsmanaging She for EFSA. charge and ofdesigning Lucia Parrino iscurrently in

DAY 3 • 20 September 58 withsocietyEngaging Massimiano BucchiMassimiano challengesthe ofscience communication 2.0 Quality ofinformation, and publicengagement SPEAKERS VrbosDomagoj post-graduate research geopoliticsofenergy. onthe European international studiesand relations did and communication bestpractices. Heis agraduate of publicperceptionsassessments, risk and of mediators’, quality the ofpublic communication introduced internet. withthe Inacontext of‘crisis scientiststhemselves,and been not hascertainly for propaganda, alsoinvolving scientific content publicrole the and ofexpertise? Mystification issues like credibility reliability and ofinformation different communicative context longstanding areAnd they entirely new orrather place ina communication ofdigitalmedia? age inthe What are key the challenges for science edu/MassimianoBucchi www.massimianobucchi.it https://unitn.academia. contributes to newspapers TV and programmes. both aseditor Trench). withB. Heregularly of Science (London New and York, Routledge,2016, four volumes PublicCommunication The anthology (London New and York, Routledge,2014) the and Communication ofScience Technology and (New York, Springer, 2009); ofPublic Handbook New York, Routledge,2004), Beyond Technocracy countries, including Science inSociety (London and has written several books inmore published than20 papers injournals such asNature Science and and Understanding ofScience Hehaspublished (Sage). multilateral organizational settings. communication related to food nutrition and in worked he assignment, inareas ofresearch and master degree indevelopment studies.Prior to this EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority international journal Public Oceania. editor Heisthe ofthe Europe, America and North research institutionsinAsia, professor and inacademic Trento, hasbeenvisiting Italyand Society University atthe of of Science Technology and in BucchiMassimiano isProfessor communications, a holds and background ineconomics and communication.and Hehasa perspectives to risk assessment providing socialscience His responsibilities relate to Cooperationand Department. Communication, Engagement VrbosDomagoj works inEFSA’s ,University ofTrento engagement, scienceengagement, communication Key words: credibility ofinformation, expertise, public Ragnar Löfstedt societies”. in “post-trust Conceptualising communicating and risk • Experience research and inrisk perception and Gothenburg University, Sweden. Professor Centre atthe for PublicSector Research, Carnegie MellonUniversity, isaVisiting he and ofEngineering PublicPolicy, and Department the education professionals. Professor HeisAdjunct at Communication Course Challenge for continuing School ofPublicHealth where directed he Risk the Harvardat the Center for RiskAnalysis, Harvard Universitythe ofSurrey, UK.Hewas alsoanInstructor Previously was he aReader inSocialGeography at research onrisk communication management. and College London, UKwhere teaches he conducts and Director ofKing’s Centre King’s ofRiskManagement, Löfstedt isProfessor the and ofRiskManagement • Present organisation position:Ragnar and E. of Surrey asalecturer insocialgeography in1993. (IIASA) (Laxenburg, Austria), University the joined he International Institute for AppliedSystems Analysis as an opportunity toas anopportunity rethink ofourkey some concepts. for ourresearchopportunities discussions,aswell and could relevant seeinthislandscape challenges and Moreengagement. such risksof in general, we prepared to deal potential dynamicsand withthe in communication always not to and ‘end-user’ the are institutions,who their and increasingly active places new greater and responsibility onresearchers contemporary communicative clearly landscape lackand failure ofand inreplicating studies.The to publishany content regardless ofitsquality, emergencethe journals’ available of‘predatory in 2002 to more 2016), than600onlyinMedline, 30cases last10years,1000% inthe rising from numberofretractedthe papers (anestimated asignificant publishing: academic and rise in major concerns world inthe ofresearch policy communication atlarge withtrends causing popularisers.and This inevitably connects science pastin the by decades, professional mediators ‘filtered’, being domain without as case was the is increasingly inreal pushed into time public the inspecialisedcontexts.published New research quality onthe dependent ofresearch produced and of science is–even more past thaninthe –highly ,King’s Centre for RiskManagement Society Policy and Group atthe doctorate Risk, positionatthe University (1993).After apost- his PhDingeography atClark respectively, before completing Clarkand University (1991), of California Los (1988) Angeles MAdegreesBA and atUniversity Education: DrLöfstedt earned his

DAY 3 • 20 September 59 withsocietyEngaging Lucia Reisch scientific not enough isgood–but facts why noise: Biases, illusions,and providing Key words: risk post-trust, communication, societies Palgrave/MacMillan, Basingstoke, 165pp. Lofstedt, R.2005. Riskmanagementinpost-trustsocieties. References putting forward anumberofpolicy recommendations. communicate risks post-trustera inthe conclude and by food related and sector ofhow to how and to not are the trusted. not InthistalkIgive examples from risk trust’asthe communicators‘post themselves worse butmade times, bestofthe the inanera of risks thatpeopleare concerned aboutisdifficult at technological rather thannatural. Communicating than voluntary, unfamiliar rather thanfamiliar, and more aboutrisks thatare seenasinvoluntary rather Research shows, for example, thatwe are allworried People perceive risks some differently thanothers. trustisequivalentindustry to low publicperceived risk. risk communication argues and thathighregulatory/ of publictrustinregulators viaproactive industry and railways.installations and Heisabeliever building inthe ofincinerators, ofbuilding siting the and nuclear waste pharmaceutical recalls, telecommunications, biosafety, areas asrenewable energy policy, food safety issues, in risk communication insuch management and risk communications: Hehasconducted research Consumer Policy (Springer). serves for15 years asEditor-in-chief Journal ofthe of of Technical Sciences ‘Economics’) (Section has and lifelong ofacatech, member German the Academy Economics, Stockholm). hasbeenelected She a Foundation, Stuttgart; Stockholm School of (e.g., Warentest, Stiftung Bosch Berlin; Robert Bioeconomy Council. servesonseveral She boards Sustainable Development aswell German asofthe German ofthe member Councillong-time for Justice Consumer and Protection (since 2014), isa Consumer Affairs German ofthe Federal of Ministry policy consultant, chairs she Council Advisory the for behaviourally based regulation. As anacademic consumption production) and aswell as consumer sustainable behaviour (inparticular sustainabilityand policy, empirical research into covering mainresearch her areas: consumer, health more disseminations than400publicationsand projects. past haspublished Inthe she decades, on several German, European and Nordic, research iscurrentlyand working asaPrinciple Investigator EFSA JOURNAL |SUPPLEMENT ,Copenhagen BusinessSchool Zeppelin University, Germany Professor atFriedrichshafen’s isalsoaVisiting She Denmark. Copenhagen School Business in European consumer policy atthe consumer research and professor for intercultural behavioural economist full and Reisch isaGerman Lucia A. for GlobalHealth Kannan Krishnaswamy communications ecosystem: caseofpublichealth the news misinformation inthe media Observing Key words: attitudes, biasesandheuristics, decisionmaking, nudges Journal ofJudgmentandDecisionMaking, 11,310–325. Reisch LAandSunstein DoEuropeans CR,2016. like nudges? Giroux, United States. Kahneman D, 2011. Thinking, fast andslow. Farrar, Straus and References the voicelessthe development canamplify atregional howand cutting-edge projects thatgive avoice to effectivenessthe by useofmedia ofthe children projects around children’s demonstrating media developmentthe sector. ledlarge he InPlanIndia, communications canbepressed into of service the learnt he journalist, how works media how and effective manner. Whileworking asa Hindu inThe for development how and inan thiscanbedone works for anorganisation communication inusing world media inthe and to gaininsightsinto what and welfare-enhancingand goal. governance, transparency agenerally and accepted canharnesssender biases,which the requires good morethem resistant to manipulation.Third, the decision-makingtheir to capacity try and make cognitive limitsofthe on the system increase and aim to Second, caneducate one out. carry people This iswhatbehavioural insights-based policies salience hence and effectiveness information. ofthe nudges’to‘informational increase relevance, the approaches. First, canmake sender the useof Thereheuristics, ‘noise’. and are basically three mustbeawaresender biases,suboptimal ofthese communication ofscientificinformation, the making formation and ofattitudes. For asuccessful doinfluenceof judgements) people’s decision systematic (i.e. chance ‘noise’ biasesand variability making, cultural group and variables, aswell as states (e.g. stressed) being ofdecision time atthe as fears, physical (e.g. tired) being neuronal and deliberative cognitive processes: such emotions preferences are shapedby much more than empirical evidence thatpeople’s beliefsand cognitiveand psychology increasingly provide However, consumer research, decisionsciences ofriskdominant mode communication for long. process to deliver information hasbeenthe Communicating scientific asaone-wayfacts both the developmentboth the sector has have in time spentenough for grassroots. peopleat the He communication skills media and communicator trainer and in public relations professional, around 27 years asajournalist, professional experience of Kannan Krishnasawmy hashad ,TheGeorge Institute

DAY 3 • 20 September 60 withsocietyEngaging The George Institute, online.Case Training study: journalists for journal_edition_fe01289db92c61 https://issuu.com/rohitkumar471/docs/health_times-ej_lab_ Health timesejlabjournal edition1.Available online: References has relevance for including allmedia socialmedia. contexts role, play this And etc. anequallyimportant systems beignored cannot cultural –orsocialand information for future interventions such asbelief for any future intervention ithasproduced valuable project was implemented second atthe level, but influence three ofthe levels on each other. Our information, which isproduced asaresult ofthe between misinformation, disinformation mal and finally, whatalsomatters isthe clear distinctions contexts thatinfluence other the two levels. And topthe level, which cultural socialand isabout the level, which isaboutgetting science the right; and formativeusually the mid- the ofengagement; part thinking (understanding context the well) which is which isaboutbelief(ourworldview) critical and are three levels ofcontent creation: base the level, fake news. information Inthe ecosystem, there essentially isallaboutunderstanding fighting and addressing disinformation the ecosystem, which approach to understanding such also issuesand directions could betaking asocialscience research takingand anevidence-based approach. Future thinking analysis, and understanding science complemented by thatcombines amodel critical was information-deficit thatthe model has to be onpublichealthreporting issues.Whatwe found skills ofjournalists studentsto media and improve atdeveloping aimed in India critical the thinking Between we 2014 2016, and implemented aproject sciencethe But thisalways right. work. doesnot write goodstories. emphasisisongetting Sothe ifthisisprovidedand, to they them, willbeableto premise isthatjournalists are starved ofinformation sidetoanother thisstory aswell. often-held The approach to covering such stories. Butthere is to media the data canhelp take amore scientific Understanding evidence,visible effect. research and invisible underlying seemingly the causebehind comprehend science the such behind events –the approach dueto which often media the fail to by alack ofunderstanding ofanevidence-based misinformationThe ecosystem ischaracterised which science ispitted people’s against emotions. public health issuessuch asimmunisationin News face media ahugechallenge incovering health ofjournalists onfake one another and news. researchOther projects include astudyonmental to research lookatdisseminating to policy-makers. advocacy ofthe as part team George ofthe Institute trained incritical appraisal skills. Hehasalsoworked Many journalists studentshave media and been programme involving evidence, research, data. and UK–to bring toprogram bear atraining from Australia Critical and Appraisal skills doctor from different geographies world inthe –media from whichreporting, combines two uniqueinnovations programme calledcritical appraisal skills for health George Institute, hasintroduced he aunique as well asglobal levels. Inhislatest stintatthe EFSA JOURNAL |SUPPLEMENT for-better-public-health-reporting https://www.georgeinstitute.org/our-impact/training-journalists- better publichealth reporting. Available online: Fabiana Zollo polarised context ofnarratives tribes and Dealing withdigitalmisinformation: a accounts for socio-cognitive the factors underlying interdisciplinarymethodological, approach that we address such achallenge by across- applying of narratives are onsocial media crucial.Inthistalk, contentbehind consumption emergence the and 2010). So, understanding maindeterminants the producing abackfire effect Reifler, (Nyhanand fail to reduce misperceptions,frequently instead to resist facts (Kuklinski etal.,2000), corrections and factual evidence. Moreover, ingeneral, peopletend are misinformed, they beliefsneglecting hold 2013). isalarming. phenomenon The people When terrorism toranging from cyber-attacks (Howell, core technological ofother geopoliticalrisks, and ofmassivedanger digitalmisinformation atthe Economic Forum global the hasbeenplacing public opinionnegatively. Since 2013 World the oftenand untruthfulrumours thatcan influence aresocial media riddled withunsubstantiated many users oftheir (Newman etal.2016). However, maininformation asthe establishing source for but alsoto civicworld, politicaland the rapidly become central onlyto not oursociallives, production. Inthiscontext, have socialmedia diffusionofcontent, onlyinthe not butalsoits new scenario inwhich peopleactively participate consumption, leading upto formation the ofa have radically changed paradigm the ofnews adventThe Internet ofthe web and technologies American, Investigatión yCiencia). Scienze, Pour Science, La Spektrum,Scientific org, ElPais) disseminated and internationally (Le Economist, Bloomberg View, Guardian, The Phys. NewThe York Times, Washington The Post, The widely covered by others: the (among media the Worldof the Economic Forum have and been have 2017 beenincluded Global inthe RiskReport Internationalnational and co-authors. Herresults has collected several papers bothwith topic, onthe collective narratives She socialmedia. ononline polarisation intolerance and evolution the and of spreading withaspecialfocus dynamicsof onthe Her research investigates (mis)information Foundation (Venice Centre) ledby ShaulBassi. International SocialChange Humanities and ,Ca’ Foscari University ofVenice Research Fellow atthe Quattrociocchi. isalso She coordinated by Walter of DataScience Complexity and fellow Laboratory ofthe member Informatics Statisticsand and Environmental Sciences, Professor of Department inthe Fabiana Zollo isanAssistant

DAY 3 • 20 September 61 withsocietyEngaging Key words: echo chambers, misinformation, polarisation, social media Facebook: aclash between tribes. Working Paper. Quattrociocchi W, Theclimate 2018. change debate on Zollo F, Schmidt DelVicarioDunlapRand AL, M,ScalaA, tribes. PLoS e0181821. One12, Havlin SandQuattrociocchiL, W, 2017. Debunking inaworld of DelVicarioCaldarelliZollo Shekhtman G, F, BessiA, M,Scala the ageofmisinformation. PLoS One10, e0138740. Caldarelli GandQuattrociocchi W, 2015. Emotionaldynamicsin Zollo F, Novak PK, DelVicarioMozetič I,ScalaA, M,BessiA, Vaccine (submitted). W, Polarization 2018. ofthevaccination debate onFacebook. BetschSchmidt Zollo CandQuattrociocchi F, AL, ScalaA, 3035–3039. 114, Academy ofScience USA, consumption onFacebook. Proceedings oftheNational StanleyG, HEandQuattrociocchi W, 2017. Anatomy ofnews CaldarelliSchmidt Zollo F, AL, DelVicarioScalaA, M,Bessi A, 303–330. persistence ofpoliticalmisperceptions. Political Behavior, 32, Nyhan BandReifler J, 2010. When corrections fail: the Oxford,Report. Reuters Institute for theStudyofJournalism. Newman N,Levy DAL DigitalNews andNielsenRK,2016. Journal ofPolitics, 790–816. 62, Misinformation andthecurrency ofdemocratic citizenship. Kuklinski JH,Quirk PJ, Jerit J, Schwieder DandRich RF, 2000. Techical onGlobalRisks. Report World Economic Forum. Howell 2013. Digitalwildfires WL, ina hyperconnected world. Advanced (DSAA),Tokyo: Analytics Japan. IEEE, referendum. International Conference onDataScience and social media:aquantitative, cross-platform analysis oftheitalian F, 2017b. Publicdiscourse andnews consumption ononline Del Vicario M,GaitoQuattrociocchi S, W, ZignaniMandZollo Debate’. SocialNetworks 50. W, 2017a. MappingsocialdynamicsonFacebook: TheBrexit Del Vicario M,Zollo F, Caldarelli ScalaAandQuattrociocchi G, 113,554–559. Sciences USA, misinformation online.Proceedings oftheNationalAcademy of StanleyG, HEandQuattrociocchi W, Thespreading 2016. of Del VicarioZollo F, Petroni Caldarelli M,BessiA, F, ScalaA, References to information mapthe space onsocialmedia. crucialrole the highlighting ofdatascience techniques development ofcore narratives debating, ononline determinantsabout the ofpolarisation the and al., 2018). Ourresults provide interesting insights Schmidt etal.,2017, Schmidt Zollo etal.,2018, et (Del Vicario etal.,2017a, DelVicario etal.,2017b, asharpeliciting polarised and community structure on alimited setofpages (selective exposure) sources natural the and tendency ofusers to focus of well-segregated groups ofusers around news which we emergence spontaneous observe the public(climateand change, vaccines) debates, in Brexit,(the ItalianConstitutional the Referendum) findings reveal thatsimilar patternshold for political contrastingand information (Zollo etal.,2017). Our investigate users’ response to bothconfirmatory between different narratives (Zollo etal.,2015), and 2016), address dynamicsinsideand emotional the contentbehind consumption (DelVicario etal., We show thatconfirmation maindriver biasisthe reinforce polarise and pre-existing their opinions. groups oflike-minded peopleinwhich users existence echo chambers, so-called ofthe polarised provide and socialmedia online empirical the We phenomenon. the analyse massive datafrom EFSA JOURNAL |SUPPLEMENT Tracey Brown We don’t live inapost-truth society together, public interest? inthe publicand withthe are? How canwe trulyembark journeys onthose how appear things how out find and they really questions, to crunch numbers? the To transcend tograppling asktestable public, the alongside naturalsense oftheir socialsystems: and are we society buthow to equippeoplebetter to make before how usisnot to inapost-truth function consult experts oncomplex question The subjects. found that86% ofpeoplewant government the to attitudepublic’s to experts,anIpsosMORI2016 poll wakein the ofpost-referendum concern aboutthe consistently strong trustsince 1970s. the UK, Inthe notedand thatthey are onlygroup the to enjoy that scientistsare stilltrusted to tell truth the evidenceand was borne outinsurveys: Pew found outcomes to police statistics.Thatinterest inscience surgery heart naturalin the social world, and from ofthings of peoplesoughttruthaboutallmanner year oftruthseeking –ayear inwhich thousands 2016 could justas easily have beenconsidered the counts for Thiswould nothing. bewrong. Infact, for persuasion orchallenge factual and credibility already disposedto hear, thatthere scope isno ofbelieving thatpeoplejusthearit, whatthey are are thatreinforce onlymemes ofseeing indanger Amidthisanxiety, faithlosing public. withthe we greater peopleinpubliclife are publicengagement, alternativeand facts. Despite appeals alltheir to how to operate inaworld ofFacebook filter bubbles research regulatory and bodiesdisturbed about Across Europe, conferences have upamong sprung word the ‘post-truth’ made year. ofthe Dictionary wanted to Oxford the articulate. In2016, English if they describe donot experience the thatpeople food energy and appear to have little had purchase gross product domestic (GDP), climate, pollution, dispensable.Announcementsseemingly about carefully assembled facts dataare and becoming standards norms and ofevidence anxiety and that serioussome publicregard questionsaboutthe for successThe ofpopulistcampaigns hasgiven rise to anOBEformade to services science. evidence-based policymaking. 2017 InJune Tracey was recognised by Science the Council for work her on in science policy inBritain in2014 and was she Traceynamed influentialfigures 10most ofthe asone evidence for claims. In2010, Times the newspaper campaign, which publicinrequesting the engages of allclinical trial outcomes; Ask the and for Evidence including AllTrials, aglobal campaign for reporting the ,SenseaboutScience launched important initiatives initiatives launched important answerpeople who to Ithas them. thinking the publicand the among campaigns to urge scientific science evidence and into popular has turned casefor the sound leadership, her Under charity the of SenseaboutScience since 2002. Tracey Brown director hasbeenthe

DAY 3 • 20 September 62 withsocietyEngaging Melanie Carr EMA’s approach to stakeholder engagement Key words: science publicengagement, communication, statistics trusted-less-than-estate-agents- journalists-and-bankers.aspx researchpublications/researcharchive/3685/Politicians-are-still- September 2016: Available online:https://www.ipsos-mori.com/ estate agents,journalists andbankers. 22January. As of20 PoliticiansIpsos MORI,2016. are stilltrusted lessthan stable-for-decades/ tank/2017/04/06/public-confidence-in-scientists-has-remained- 6 April: Available online:http://www.pewresearch.org/fact- has remained stablefor decades.Pew Research Center, Funk CandKennedy B,2017. Publicconfidence inscientists society. British MedicalJournal, 355, i6467. Brown T, Evidence, 2016. expertise,andfacts ina‘post-truth’ Available online:http://eprints.lse.ac.uk/48813/ of Economics andPolitical Science. As of20 September 2016: in thenetworked public sphere. London London,School POLIS, Beckett Communicating 2012. C, for change: mediaandagency References interestingsome lessonsfor discussion. our public-led, expert-fed approach hasserved up collaborate more effectively. At SenseaboutScience, abouthowimagination to communicate and accountability; itexpands and oursocial to publicempowerment democratic and monitoring, regulating are assessing and key Working publicreminds withthe usthat more specific frameworks morefor interaction specific with Agency the withthese, Aligned hasdeveloped in place for itstakeholder managing relations. Today, EMAhasanoverarching setofprinciples has consistently given priority to such interaction. groups value added the and thisprovides, and forneed interaction withitsvarious stakeholder Since itscreation in1995,EMAhasrecognised the with formal to appointment thatpositionin2018. Communication interim Divisiononanad basis, took role onthe ofHead ofStakeholders and Corporate Stakeholders in2016 and Department she Office. In was appointed2014, Head ofthe initiative, setting EMASME the running upand responsible for Agency’s the implementing SME Products (COMP). From 2005 to was she 2014, setting Committee upthe for Orphan Medicinal EU legislationonOrphan MedicinalProducts and EMA taskforce responsible for the implementing Authorisation. In1999, ofthe amember became she forManager Centralised Applicationsfor Marketing Substances Sector Agency ofthe in1998asaProject transferred1996 and to New the Chemical Pharmacovigilancethe EMAin ofthe department EFSA JOURNAL |SUPPLEMENT ,European MedicinesAgency Agency for 22years. joined She hasbeenworkingand atthe (EMA). Melanieisapharmacist European Agency Medicines Stakeholders atthe Department Headacting Corporate of the Communication Divisionand Stakeholdersthe and Melanie Carr iscurrently Head of Key stakeholders words: EMA, Other/2016/06/WC500208987.pdf http://www.ema.europa.eu/docs/en_GB/document_library/ online: EMA Stakeholder Relations ManagementFramework. Available References Leonie Dendler Institute for RiskAssessment German the Federal perspectives from consumer protection: practices and stakeholdersEngaging inscience-based Assessment networks haswritten, and reviewed edited and for board ofseveral member international research systems focus onfood. withaparticular isa She across international consumption production and lies inunderstanding institutionalchange processes SchoolBusiness widerresearch (UK),her interest Manchester scientist by training withaPhDfrom Fudan University (China).Anenvironmental Research University atthe ofManchester (UK)and Institute Tyndall the and Centre for Climate Change previously worked for SustainableConsumption the science-based consumer protection. has She and contributionand thismakes to publichealth. stakeholders) confirms and initsactivities the value continued active involvement ofpatients other (and making. Agency The isfullycommitted to the input inbenefit–risk evaluationadds to decision once clear made again value the thatpatients’ ofvalproate.assessment success The ofthis hearing public hearing regulation onmedicines during its In 2017, Agency the implemented first the EU areengagement constantly developed. being level to date. New for methods interaction and in nearly 900different highest the EMAactivities, onto market. the In2017 patients alone, participated to safety monitoring once are medicines released early development ofbenefit–risk assessment and throughout entire the life cycle –from ofmedicines regulation.point inmedicines Patients are involved patients iscurrently acknowledged asareference developed, EMA’s and for model with engaging consumers are perhaps mature most the fully and interactionsfour withpatients frameworks, and to beusedfor witheach engaging group. Ofthe objectives to beachieved methodology the and the identify frameworks These academia. and consumers, healthcare professionals, industry each ofitskey stakeholder groups: patients and ,German Federal Institute for Risk and public engagement in publicengagement and on stakeholder management Herproject focusses department. riskwithin the communication prevention coordination and unit Assessment working for crisis the Federal Institute for Risk research fellow German atthe Leonie isapostdoctoral Dendler

DAY 3 • 20 September 63 withsocietyEngaging communication, stakeholder management Key words: risk risk publicengagement, assessment, consumer protection. context inthe management ofscience-based prospects potential and pathways for stakeholder presentation willclose withareflection onfuture science, government society and The asawhole. what callsfor more implyfor publicparticipation lay for need outthe amore opendebate about widersocietaldiscoursewithin politicaland and presentation willpoint to current contradictions discursiveand challenges. the Inparticular, process. include These epistemological, regulative for risk ofthe opening aparticipatory assessment presentation ofthe part willfocus onchallenges as well widersocial context. astheir second The clear understanding goals oftheir priorities and leadership butalsoa organisational and support address organisations these, onlystrong not need As aresult, anumberofconflicts emerge. To we move purely outofthe profit-oriented realm. it willshow how normative increase demands as processof planning, outcome and related criteria processes.management Summarising three sets for successful the ofstakeholder enactment criteriapresentation lightonimportant willshed Drawing ofthe first data,the uponthese part stakeholders 1,004 and members public. ofthe organisations astructured and survey of414 BfR governmental, corporate, media and academic governmental, supragovernmental,from non- 40 qualitative interviews withBfRstakeholders researchthe involves observations, participant to literature reviews analyses documentary and context ofscience-based consumer protection. Next for successful stakeholder inthe engagement barriers potential and pathways implementation BfRiscurrentlythe investigating facilitators, consumer health protection. Against thiscontext task to conduct risk independent for assessment for RiskAssessment statutory (BfR),withthe organisations, such German asthe Federal Institute that such alsoextend demands to publicscientific as normative ofargumentation. lines Many argue at large, which their find roots instrategic as well ingovernanceengagement societalprocesses and callsforThis buildsonlongstanding more public non-governmental organisations. academic and been increasingly discussedfor governmental, corporations. More recently, itsrelevance has asakeyestablished variable for success the of Stakeholder been haslong management Journal ofCleaner Production Energy and Policy. different peer-reviewed journals, including the EFSA JOURNAL |SUPPLEMENT Environmental andOccupational Health &Safety Key words: civilsociety, expertise, publicengagement Régine Fraysse-BoutraisRégine Occupationaland Health Safety and (ANSES) Frenchof the Agency for Food, Environmental upexpertiseto Opening civilsociety: casestudy in sharing scientific knowledge. recommendations opinionsand of the delivered and infacilitatingpublic engagement understanding the This talkwilldraw conclusions some of impacts onthe finally to feedback training and meetings sessions. process through hearings consultations and and are alsoinvited to contribute to risk the assessment nanomaterials orpesticides.They radiofrequencies, aPlatformand oncontroversial issuessuch as Steering Committees, three DialogueCommittees governance bodies:Board ofDirectors, five Thematic process.assessment Stakeholders are involved in various levels ofgovernance risk the along and has resulted inseveral processes participatory at ofthischarter implementation The withinANSES favour capacity and publicengagement building. share scientific knowledge uncertainties, and usedinrisk methods and expertise assessment, three-fold: improve transparency results onthe of Agency’s commitments towards civilsociety are sanitary/environmentaland The risk assessment. public organisations inFrance dealing withresearch toexpertise society hasbeenendorsed and by seven aimsatpromotingdocument upof opening the stakeholders, acharter ANSESsigned in2011. This public debate ofdeveloping and relationships with ofitsglobal processAs part ofcontribution to • • • • progress, work common and well-being’. Master degree incharge division‘Social ofthe Development ‘Sustainable the Organisations’ and University educational team ofthe member and of Professor in Environmental Health, Paris Dauphine Health Safety, and 94MAISONS-ALFORT Agency for Food, Environmental Occupational and Society Science for Unit, Expertise Division,French stakeholders since 2010 SocialSciences Expertise and InchargeSociologist, ofdeveloping relationships with Current positions: (IAE) PARIS, 2004. Sorbonne University –Sorbonne School Business Master ofNGOs,Paris inManagement Panthéon University, 2005. Development Organisations, and Paris Dauphine • way to questiondevelopment? environmental health issues:A aroundof NGOsmobilisations dynamics ‘The onthe Thesis University,Dauphine 2011, • Education: Master inSustainable PhD inSociology, Paris ,F rench Agency for Food,

DAY 3 • 20 September 64 withsocietyEngaging assessment, scienceassessment, andsociety Key words: openriskopenness, engagement, assessment, Didier Verloo with society. Steps taken direction and to go scientific Optimising value through engagement assessment protocolsassessment to innovation crowd sourcing. stakeholder publicconsultations and onrisk from given onhow EFSA ismoving forward onthisgoing societal expectations. Several examples willbe from societalinteraction have and evolving benefit transparency; (4) and Allfour principles engagement. rigour; (2)methodological (3) impartiality; (1) being: of accomplishment offour principles fundamental expectation inscientific value degree based onthe of how far EFSA the advice scientific meets the values scientificquality becomes then measure the scientificquality.and Guided EFSAby the core is anobvious direct linkbetween societalexpectations customer sogiven needs’ ‘meeting EFSA’s role there ISO quality standards, management quality means scientificqualitythe advice ofthe given. Following advice, to hence importance the measure define and unbiasedscientific and sound methodologically Good managerial decisionscanonlybebased on recommendations to inform managerial decisions. EFSA provides uponrequest scientific graduated asaveterinarian in1995. construction, finance engineering. and Didier provided risk analysis consultancy inpublichealth, epidemiology, risk analysis, test validation and experience hands-on and academic inbiostatistics, infectious diseases. Over years the hasbuilt he up areamainly inthe ofantimicrobial resistance and government risk asanepidemiologistand assessor 2000–2005sickness) for Belgian the worked and from (sleeping animaltrypanosomiasis human and decision making based test ondiagnostic results in EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority interpretation medical and development ofdiagnostics, of Tropical onthe Medicine professional career Institute atthe since Didierstarted his 2008. Unit Support Methodological and been heading Assessment the EFSA since 2005, where has he Didier Verloo hasbeenworking for Michelle Patel regulatortrust inthe food the and system) reshaping information strategies (to improve Social research-based processes engagement together common insights from the‘Efficacy ofRecalls’, together common insights from Food Standards Agency, 2017. FSABringing Synthesis Report: https://www.food.gov.uk/sites/default/files/our-food-future-full-report.pdf Food Standards Agency, OurFood 2016. Future, 52 pp. Available online: consumers-of-food.pdf https://www.food.gov.uk/sites/default/files/identifying-activist- food. Available online: Food Standards Agency, consumers activist Identifying of 2016. References increasingly complex world. a regulator food trustinthe and system inan knowledgein asound ofwhatdrives trustin base locate thatwillhelp UKfood policy decisions intentionThe isto continue to develop anevidence information food. abouttheir on consumers’ expectations for transparency of widerfood the and system (OurFood Future) and connectionstudies onthe between consumers elsewhere, including ourpreviously published together FSA withexisting the and research from Finally, apeer-reviewed synthesis brings this workshopsand civilsociety. and withindustry trust inindustry, food the system inregulators and covering contemporary the drivers barriers and to In parallel, we conducted aliterature review to explore trustwithcitizens. Walesdialogues inEngland, Ireland Northern and composite measure iterative and for trust, public quantitative work to inform development the ofa includes quantitative tracking, more in-depth regulator, amultimethod using approach that We explore food trustinthe system its and take for granted, canafood nor and business. communicating science to protect consumers can thatanorganisationsomething witharole for where we expect significant not thisis change, information. Inanincreasingly world uncertain rise democratisation the and ofsocialmedia of commentators this‘crisis blame oftrust’onthe hasdeclined. media and NGOs, business Some suggests thatworld-wide, trustingovernment, is ‘Food we cantrust’. However, current discourse FoodThe Standards Agency’s (FSA’s) strategic aim Wales Ireland. Northern and offoodmanagement risk safety and inEngland, of humanbehaviour informs and assessment the ,UKFood Standards Agency ensures understanding thatthe leading team the FSA, that SocialSciencethe at function Government, Michelle now runs communications roles withinUK marketing, insightand Standards Agency insenior and Communications Food atthe After asDirector serving of

DAY 3 • 20 September 65 withsocietyEngaging Pierdavide Lecchini communication activities involvementThe ofcivilsociety inrisk Key words: dialogue,reputation, research, socialresearch, trust Food Standards Agency, Trust 2018. inachanging world (forthcoming) fsatransparencyreport.pdf https://www.food.gov.uk/sites/default/files/media/document/ views andpriorities. Available online: Food Standards Agency. Transparency –understanding public fsasynthesisreport.pdf https://www.food.gov.uk/sites/default/files/media/document/ (November 2017). Available online: ‘Regulating ourFuture’ and‘Transparency’Research Reports specific section called‘Consultaspecific section delleassociazioni having competence infood feed and issues.A constructive dialoguewithpublicauthorities out through abodythatallows aconstant and consumer producer and associations.Itiscarried involvementthe ofstakeholders represented by ofHealth,Ministry hasalways asitsmission had of Collegial bodiesfor health protection ofthe communication, located Directorate-General atthe nationalauthorityItaly’s for risk and assessment in May 2018 General3 ofthe Secretariat ofHealth Ministry ofthe took uphiscurrent positionofDirector Office ofthe Veterinary ofHealth. Ministry ofthe Medicine He Generalof the Directorate for AnimalHealth and of Director animalhealth ofthe crisis and unitoffice From March 2016 to April role served inthe he 2018, European Council European the and Commission. Health to sectorial the working groups ofthe spokesman for delegate Italyand of Ministry ofthe Permanent Representation to EU. the Heacted as Safety Pharmaceuticals and Italian withinthe as anexpert inHealth, Veterinary matters, Food veterinaryand matters, inthatcapacity and served ItalianDelegate the became he to EUfor the health to EU, the food safety animalwelfare. and In2007, twinning projects withThird Countries for accession international trade, border postcontrol, inspection roles, management and withresponsibilities for Pierdavide Lecchini worked innumerous veterinary veterinary authority in1991. Over a16-year period, mixed veterinary practice government the joined University ofParma, Italy, after and five years in University the ofPisa the and legislation from animal origin European nationaland and veterinary veterinary science, control offood feed and of hisBachelorgained Master and degrees in food, veterinary collegial and medicine bodies).He EFSA JOURNAL |SUPPLEMENT relationships, communication, research, international (covering health prevention, ofHealthItalian Ministry Generalof the Secretariat ofthe health. HeisDirector ofOffice 3 health veterinary and public veterinarian, anexpert inpublic Pierdavide Lecchini isa ,Italian ofHealth Ministry Key words: involvement, risk communication, stakeholders pdf [InItalian] http://www.salute.gov.it/imgs/C_17_pubblicazioni_2652_allegato. Perché, come ecosa èimportante comunicare. Available online: Ministero dellaSalute, 2017. Irischi insicurezza deglialimenti: alimentare&menu=comitato [InItalian] jsp?lingua=italiano&area=Valutazione%20rischio%20catena%20 portale/rischioAlimentare/menuContenutoRischioAlimentare. rischio alimentare. Available online:http://www.salute.gov.it/ Ministero dellaSalute, Valutazione 2016. ecomunicazione del References approaches. communicators ofinnovative adoption the and and involvement the and ofbothspecialisedpress members, concern for training programmes, its structure contents and shared Council withthe relevantOther thatwillbeillustrated activities are a proper risk communication food inthe sector’. involved incommunication for ‘Guidelines the and based oninformation for documents allthose undertaken during recent years are described, General Committee. the and Mainactivities as aboostfor activity the Directorate- ofboththe sourcea further requests, ofquestionsand aswell technical Italso scientificsection. and represents for mainmeasures thathave beenadopted by the citizens. Therefore board itserves asasounding conscious consumption healthy and dietamong comparing sharing and information to facilitate Food Safety). Council The represents forum the for sicurezza alimentare’ (NationalCommittee for works ‘Comitato withinthe nazionaleperla of Producer Consumer and Associations) actively dei produttori edeiconsumatori –CNSA2’(Council

DAY 3 • 20 September 66 evidenceManaging Managing evidenceManaging provide fit-for-purpose risk assessments? this diverse bodyofevidence beusedto asevidence?right dataserving How can targeting, analysing accessing and the address challenges the ahead –are we intelligence, artificial and sessionwill the approachesand such asmachine learning requirementsBesides the ofnew tools science. contextdata inthe ofregulatory-driven accessibility, analysis useand right ofthe how,with the why whatand linked to challenges and associatedopportunities this data? Thissessionwillinvestigate the But how dowe explore analyse and all evidencethe base for risk assessments. explosion ofdata,potentially increasing worldThe through isgoing anexponential EFSA JOURNAL |SUPPLEMENT Committee for Food andEnvironment Mary Gilsenan Mary CHAIRS Danica Grahek-Ogden PhD in dietary exposure from Trinity College, exposurePhD indietary Dublin. from University the ofUlster a and human nutrition from College, degree aBachelor’s holds in Dublin.Mary researcher food inthe industry, aswell asatTrinity Leatherhead Food Research, worked and asa at Global Department Regulatory Services Before the managed Mary EFSA joining in2012, • • • business riskbusiness food withinthe sector asamainfield. microbiological risk (biorisk) assessment and safety risk and area inthe management of in Aberdeen, withfood UK)asasenioradviser Det Norske Veritas (inNorway for and ayear training.and internal change management, assessment, audit of risk factors process using risk mapping, involved identification, ranking mitigation and farm to fork’.throughout chain the ‘from Projects to ensuring bodiesand funding food safety research development and projects, reporting Priorand Norge BAasproject for manager MATFORSK (Norwegian Food Research Institute) laboratory. Food Safety Authority asamicrobiologist atthe work infood microbiology. movedand to Norway continued 1994and to Ruder Boskovic atInstitute for Marine Research ,European Food Safety Authority EFSA’s scientific assessments. chemical hazards, to support food-borne biologicaland food consumption, aswell as on publicationof(meta)data and collection, collation, management where isresponsible she for the Evidence Unit, Management Gilsenanishead ofEFSA’sMary a microbiologist Institut at the • School.Norwegian Business the degreeManagement from Masters ofExecutive University ofZagreb hasa and educated asDVM atthe Danica Grahek-Ogden was First employment was as ,NorwegianScientific

DAY 3 • 20 September 67 evidenceManaging Fabrizio Abbinante RAPPORTEURS Hans Verhagen a visiting professora visiting University atthe ofUlster. toxicologist is and aboard-certified nutritionist, and University ofMaastricht. Heisaboard-certified the hasaPhDintoxicology and Nijmegen, from University the Master’s degree from inchemistry related to toxicology nutrition. and a Heholds till 2015. widelyonsubjects Hanshaspublished He was ofEFSA’s amember 2006 NDA Panel from Universitiesthe ofMaastricht, Ulster. and Nijmegen HanshasworkedEFSA. for Unilever Research at and • • • microbiological Forum. risk Advisory and assessment Norwegian representative inEFSAs: network for evaluation jobIam ofthe As project. ofthe apart tobudgeting and assessment delivery offinished an expert panel, project from management field. Jobincludes coordinating the work of risk ofbiologicalhazards assessment asamain Norwegian PublicHealththe Institute) with scientific committee for food safety of (as part I ampresently employed Norwegian inthe delivery oflecturesand training and sessions. ofscientificprojects,management preparation tasksbodies. Other included development and to reporting and international nationaland response to ofoutbreaks management and maintenance ofsurveillance database, rapid food safety authorities, development, useand role foran advisory health institutionsand zoonosisand asamainfield.Jobsincluded jobs included tasks withfoodborne diseases At Norwegian Institute the ofPublicHealth CAMPEC net. ofEU’smanagement SAFEFOODERA project Norwegian Veterinary Institute –project EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority Food Research Institute, in and Environment, TNONutrition and for PublicHealth the and NationalInstitutepositions atthe sector. management Heheld private publicand both inthe years ofprofessional experience, adviser.scientific Hanshas 35 Hans Verhagen isEFSA’s senior several projects area inthe of (2004–2008). Hehasmanaged European Agency Medicines for EFSA (2008–2014) the and Analyst ITBusiness and Manager Programme. HehasbeenaData Information Management programme ofEFSA’s manager Fabrizio Abbinante ispresently ,European Food Safety Authority Claudia Cascio Ermanno Cavalli computer engineering from the University the ofBologna. computer engineering from technological experience. HehasaMaster’s degree in developed managerial asound role built onstrong software developer tofrom system engineer. Hehas tomanager CIO, plus10years intechnical roles, software developmentmanagerial roles, from information technology, ofwhich years 20+ in Ermanno hasintotal years 30+ inmanaging previously and 2006, worked private inthe sector. University DeMontfort ofLeicester.from University ofCatania, aPhDinbiochemistry holds and the economics ofcultural heritage bothfrom degreedegree in asupplementary inbiology and nanomaterials atSuperLab. hasaMaster’s She researcher incharacterisation ofsurfaces and Aberdeen. Before 2007, worked she asjunior Environmental Sciences University ofthe of research Institute assistantatthe ofBiologicaland UniversityMontfort ofLeicester ashonorary and Facultythe ofHealth Life and Sciences De ofthe inEU.elements worked She asresearch assistant at assess humanexposure to arsenic trace other and researcher working onbiomonitoring studiesto Claudia was aMarie Curie Early Actions Stage JointResearchthe Centre. From 2007 till2010, Institute for Health the Consumer and Protection of of Food Safety Wageningen ofthe University and engineer at the University atthe engineer ofPisa. Agency. Hegraduated in2002 asasoftware ‘EudraVigilance project’ European atthe Medicines developer, analyst asanITbusiness then inthe Fabrizio worked first asasoftware for Bassilichi SpA, ingeneral.management From 2002 to 2004, standards, controlled terminology information and harmonisation, web interoperability, reporting, data data warehousing, datacollection, data ,European Food Safety Authority ,European Food Safety Authority Risk Assessment, RIKILT-InstituteRisk Assessment, Germanthe Federal Institute for researcher for in nano-analytics Claudia was postdoctoral since 2017. Before EFSA, joining Evidence Unit Management Assessment Team ofEFSA’s scientific officerthe at Exposure Claudia Cascio hasbeena been employed by EFSA since strategy architecture. and Hehas responsibility for technology with transformation ofEFSA, involved digital inthe UnitwhereServices is he at EFSA’s DigitalTransformation scientific officerand team leader Ermanno Cavalli isasenior

DAY 3 • 20 September 68 evidenceManaging and Regulatory Advisers Robert Madelin Robert Triangle ofPolicy inadataage Evidence we canbelieve Bermuda in:the SPEAKERS Paul Devalier computing: high-performance ofbigdataand age in the Science for risk ismaking assessment hugestrides Europe’s Missionto Innovate (2016). Now: Opportunity report ofthe author isthe he and European the and in UKpublicservice Commission digital transformation leader. • • • • • • and empowerment, as well as risk management, as well asrisk management, empowerment, and human society’s interms needs ofexplanation with whatweBy re-engaging know about leader global inthe risk community: Europe stillacreative respected and thought can guideusinto coming the with decades, existing the adjustment, But withmodest model a driver ofdemocratic policy. risk science dataage, inthe islostas it confronts for absenceIn the society, ofnew frameworks as Fourthongoing Industrial Revolution. dissonance, dystopia distrustand around the evolutionThe gapdrives much cognitive ofthe evolves humanmind the atadifferent rate. revolutionaryThese changes affect aworld where steps.management for lighteropportunities stillmore and effective maintenance ofrisk knowledge create and dynamic datacanbothimprove iterative the Real-world real –and –evidence time from Science canfeed ever clearer faster and risk assessment. EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority ,Foresight International Policy for People’. Hisprevious career was launched European initiative ‘AI Committee recently ofthe Ltd. Scientific Heservesonthe consultancy Fipra International Chairman publicaffairs ofthe Technology Global and Affairs, and at Oxford University’s Centre for isaVisiting Madelin Robert Fellow sector before asEFSA’s serving information officer privatefor the University, servedaschief and science history and atBrown Hetrainedbusiness. incognitive application oftechnology to experience inleading the technologist with30years of Paul Devalier isaEuropean Nikolai Constantin Brun Agencies challengesThe ofBigDatafor European Claudia Pagliari challenges and opportunities industry: Blockchain for goodgovernance food inthe emerging technology policy and landscape, ICT datafor and health. Thisincludes analysing the researchhas alongstanding interest use of inthe leaders new ofthe NHSDigitalAcademy. DrPagliari for perspective. ataEuropeanongoing level, around and world the talk willaimto enlighten audience the work onthe are looking to solve challenges. ofthese some The Big DataTask Force co-chaired by speaker the we EuropeanIn the Agency Medicines (EMA)/HMA of patients. arriving atevidence-based decisionsfor benefit the forbut alsomany new opportunities ways of Real World Evidence is,however, fullofchallenges Real Worlddecision makers. path The from Datato are increasingly becoming available for regulatory Big Data,i.e. Real World Data, inlarge amounts Task Force. BigData Co-ChairHe isActing EMA/HMA ofthe Veterinary MedicalEvaluation. bothfor 2018, asof1June and, Humanand responsible for MedicalEvaluation Biostatistics and His hasspent1.5years asMedicalDirector • ‘compliance friction’. toolsand thatoffer better results withlower underpinalso guideand changes the inmethod safety systems scientific stand, evidence can By focusing outcomes onthe for which food institutions canbetter fulfil their ever-legitimate roles. ,University ofEdinburgh impact journals.impact listofpublicationsinhigh- long Pharmaceutical Industry, witha pharmaceuticals Biotech inthe and research development and of clinical afterward fieldand inthe experienceand for 17years inthe Nikolai background Brunhashad C. and is one of the academic academic ofthe isone and programme inGlobal eHealth Research Group masters the and interdisciplinary eHealth school.medical leads She the University ofEdinburgh’s programme director atThe senior researcher a eHealth and is Claudia Pagliari PhD, BSc, FRCEP ,DanishMedical Agency

DAY 3 • 20 September 69 evidenceManaging “ Hartung Thomas Toxicity ofchemicals Software Beats AnimalTesting atpredicting health, supplychain, transparency prevention, globaltrade, governance,fraud regulation, public Keywords: accountability, blockchain, consumer protection, machines mighthelp. innovations intelligence such asartificial social and be ableto perform to prevent this,aswell ashow regulators and consider industry whatthe might potentially besubverted by vested interests, and waysof the inwhich machine’ thisnew could ‘trust a note ofcaution,however, itwillalsoexamine some improve and Injecting consumerreduce trust. fraud promote transparency, traceability, accountability, present examples to show how usedto itisbeing hype the surrounding blockchaintruth from and regulator, enforcer, Itwillseekto etc.). separate the chain (producer, distributor, retailer, consumer, perspectivethe ofdifferent actors food inthe supply technology examine and itsvalue proposition from briefly explain the concept ofdistributed ledger been proposed asasolution.Thispresentation will governance challenges for which blockchain has faces globalThe food industry important testing companies. direct-to-consumer genetic information from surveillance research, and quality and ofonline useofcrowdsourcing the media, for health social ethical challenges from ofbigdatamining research councils researchers and to the handle littleand income countries; readiness the ofUK enablers of transparency accountability and inlow include role onthe reports her ofICT innovations as organisationaland accountability. Recent examples governance, bothinterms ofinformation practices focus onpatient/consumer protection, policy and blockchain. Underpinning research her isastrong mHealth, assistive robots, bigdataand socialmedia, innovationsstudying such asremote telehealth, scale NHSICT programmes, implementation and synthesising research evidence, evaluating large- the GoodRead-Acrossthe Practice Collaboration, Toxicology Collaboration (http://www.ebtox.org), CAAT secretariat the hosts Evidence-based ofthe AltWeb (http://altweb.jhsph.edu). jhsph.edu) ofbothuniversities portal withthe Alternatives to AnimalTesting (CAAT, http://caat. Konstanz, Germany; alsoisDirector he ofCenters for for Pharmacology Toxicology and atUniversity of EFSA JOURNAL |SUPPLEMENT ,CAAT Europe joint appointment asProfessorjoint appointment Health, Baltimore. a Heholds Bloomberg School ofPublic atJohnsHopkinsImmunology Molecular Microbiology and forwith ajointappointment for Evidence-based Toxicology Doerenkamp-Zbinden-Chairthe MDPhD, Hartung, Thomas is chronic toxicity. aquatic Predicting 190,000 toxicity inhalation toxicity, mutagenicity acute/ and irritation, skin sensitisation,acute oral/dermal/ resultsThe are focused skin/eye on9endpoints: 74deduced different from features. achieved by datafusion,i.e. each prediction was learning.for supervised Aboost in predictivity was to define similaritychemical and feature vectors fingerprintscombine binary Jaccard and distance activity relationship) usesmachine learning to approach, calledRASAR(read-across structure ofchemical RAmethod the classification.new The constructedThe automate models extend and on physicochemical toxicological and endpoints. 800,000 chemicals withmillionsofinformation Program to 10millionstructures, including USNationalToxicology the PubMedand from Today, system the hasexpanded withdata of 81%(balanced accuracy, sensitivity 70%) was found. animals insafety testing inEurope), areproducibility toxicity tests for reproducibility (consuming 55% of available. Analysing common 6most the OECD improve toxicity predictions exploiting bigdata the a computer-readable format, itwas possibleto after aproper transformation records ofthe into numberofsubstancesthe was about10,000 and database ofregistered substances. At thattime, throughand analyses the ECHA datainthe ofthe in 2014 to develop GoodRead-Across Parctice Europe USand in the hasstarted aRAx program CenterThe for Alternatives to AnimalTesting (CAAT) regulators. and ofindustry engagement with the (www.eu-toxrisk.eu) works on8casestudiesRAx of RAx European the dataand project EU-ToxRisk Framework (RAAF) to formal guidethe presentation Read-Across their has published Assessment better regulatory acceptance. For example, ECHA approachthe scientificendorsement the and for common goal ofimproving robustness the of This triggered new general initiatives withthe to avoid new tests onanimals. 2013,and RAx resulted predominant asthe method submitted after first the REACH deadlines in 2010 RAx.Relationship) and Byanalysing data the including QSAR(Quantitative Structure Activity possibilitythe non-testing ofusing opportunities, probably first the regulation that formally gave substances. REACH (Regulation1907/2006) was by comparison ofknown ofsimilar properties approach to estimate toxicity the ofasubstance toxicity ofnew chemicals. Read across (RAx) isthe available, raising ofpredicting hope the the Much chemical safety information isnow publicly authored more than530 scientificpublications. Alternative (ECVAM), Methods Ispra, Italy, has and Commission’s Center for Validation the of formerHe isthe Head European ofthe asanNIHTransformativefunded Research Grant. Human Toxome project (http://humantoxome.com) Refinement Working Group. As headedhe PI, the Green Toxicology Collaboration Industry the and GoodCellthe Culture Practice Collaboration, the

DAY 3 • 20 September 70 evidenceManaging Steven Sloman Ignorance Community the and ofKnowledge Relationship (RASAR),machine learning, bigdata Key words: toxicity prediction, Read Across Structure Activity read-across. ALTEX, 33:83-93. 2016, bigdataintoxicology T.Hartung by Making bigsensefrom 2008-2014. ALTEXunder REACH from 33(2), 95-109 T,Hartung Safety 2016. Datafor 9,801 Substances Registered Luechtefeld T, RussoDP, Maertens RovidaZhuHand A, C, to ChemicalHazard ALTEX, Assessment, 34:459-478. Luechtefeld T, TandHartung 2017. Computational Approaches doi:10.1039/C8TX00051D. toxicology anditsuseinriskToxicological assessment. Research, andmachineBig-data learning to revamp computational Luechtefeld T, RowlandsT, CandHartung inpress. 2018, https://doi.org/10.1093/toxsci/kfy152 Animal Test Reproducibility. Toxicological Sciences, kfy152, Across Structure Activity Relationships(RASAR)Outperforming Machine Learning ofToxicological BigDataEnablesRead- Luechtefeld T, Marsh D, RowlandsT, CandHartung 2018. References (sensitivity 89%). RASARresultedbe assessed,the accuracy in87% tests, where animalstudyreproducibility could surpass predictivity the ofanimaltests. For six the specificities high sensitivitiesand to equalor even classifications of this chemicals, system provided know from the knowledge the thatresides people’s inother know from how work things we and fail to whatwe distinguish by shared intentionality. Ourcommunities understand is thatwe live ina community ofknowledge, guided reasonthe we live inthisillusionofunderstanding understanding ofpoliticalpolicies. Iwillargue that common We objects. similarly overestimate our think they do. We overestimate our knowledge of people know lessabouthow work things thanthey reveals anillusion ofexplanatory depth.Typically, Asking peopleto explain how works something outinMarch,came 2017. Knowledge Illusion:Why We Never ThinkAlone, Press. Hisrecent bookwithPhilFernbach, The World ItsAlternatives and withOxford University bookCausalthe Models:How We ThinkAboutthe todecide whatactions take. In2005, published he world works influenceshow we evaluate events and conversation,and how and ourconstrual ofhow the interactthought to produce conclusions, conflict, world, how different the systems thatconstitute influencehabits ofthought the way we seethe studies how Hehasstudiedhow peoplethink. our Cognition. Steven isacognitive scientistwho Michigan. Heisex-Editor-in-Chief journal ofthe EFSA JOURNAL |SUPPLEMENT ,Brown University for 2years University atthe of didpost-doctoralthen research 1986–1990and University from PhD inPsychology atStanford worked Hedidhis since 1992. University, USAwhere has he Psychological Sciences atBrown Cognitive, and Linguistic, Steven SlomanisaProfessor of Irene Pasquetto Technicaland Challenges DatatoManaging Evidence: Manage Social will bepresented talk. inthe examples ofhow such challenges canbeovercome novel strategies for credit attribution. Concrete trust towards dataproducers, the designing and specialised skills knowledge, tacit and promoting data quality relevance, and providing access to be taken into consideration. include These ensuring goods), asetoftechnical socialfactors and to needs commodities’ (i.e. inherently interchangeable results. Butfor research datato perform as‘fungible train predictive algorithms, orreproduce prior scientists canperform large-scale meta-analyses, accessing combining and multiple datasets, returnthe oninvestment (ROI)onresearch. By process, avoids maximises and duplicationofefforts, data reuse scientificdiscovery speeds upthe stakeholders. From agency’s afunding perspective, have recently traction science gained among sharingthe reuse and ofresearch datasets shared inbetween laboratories. Calls for increasing accessed onopendigitalrepositories, either or novel analyses ofavailable datasets that hasbeen originator.the practice Itisthe ofconducting to ofadatasetby usage the than other someone challenges ofreusing research data.‘Reuse’ refers This talkexamines technical socialand the code infrastructures. ofgovernanceimplementation for models dataand work,her Irene aimsatinforming designand the archiving reusing and climate-change data.With identity,open data,and challenges onthe of testing, ancestry onissuesofgenetic published software. dataand biomedical hasalso She ethical challenges related to opencirculation the of investigated socio-technical, epistemic, the and policy-making. For doctoral her research, Irene technologies, especiallyinrelation to science analysisthe ofdata-centric scientificpractices and economies. Heroverarching research interest liesin informationmanagement, data ethics,and teaches co-teaches and classes ondata whatever ofsociety itresides. part ideas for offerreting importance the outexpertise in heads. Iwilldraw implicationsofthese ofthe outsome ,University ofCalifornia for Society She Genetics. and Institute UCLA inthe (PartLab) Participationalso atthe Lab and Knowledge Infrastructures Center UCLA assistant atthe for where works she asaresearch Information StudiesatUCLA, of Department the Ph.D. from Irene Pasquetto her obtained

DAY 3 • 20 September 71 evidenceManaging Peter Pirolli challenges ofincorporating intelligence artificial Human-computer sensemaking the and models Cognition occur day. withinthe learning events much atthe briefer scalesthat time change (weeks, to months) intervention and decomposing bridging and long-term behavioural domains ofbehaviour-change psychology, and for integrating vaguely specialisedand specified intelligence artificial and provide opportunities achievement. Computational cognitive models of observed intervention effects ondailygoal into individual-level dynamics simulationsofthe (self-efficacy intentions) implementation and theories’ interventions ofthese aboutsome Computational cognitive‘macro- refine models improve achievement buildself-efficacy. and intentions goals and thatare personalised to groups, self-affirmations,support implementation ‘scaffolding interventions’ such assmallonline (e.g. eating habits,exercise, physical activity) using we formation guidepeopleinthe ofhealthy habits series ofmultiweek health mobile studiesinwhich present ourFettle+ research project ona from predictivemodels). Iwill dynamical fine-grained (e.g. measurement, invivo experimentation and for advancesopportunities inscientificpsychology everyday environments, they and offer incredible behaviourtheir ecology actual inthe oftheir peopleinmonitoringsupporting changing and such Internet asthe offer ofThings, novel ways for (mHealth) systems pervasive and technologies for more deaths Mobilehealth thangenetics. behaviouraland environmental and factors account to changeable smoking), behaviour fitness, (diet, It isestimated that70% ofhealthcare costs are due Academy, NationalAcademy the and ofInventors. Education, ACM the Computer-Human Interaction Psychological Science, NationalAcademy the of for Association Association Div21),the (Div3and Advancement ofScience, American the Psychological Fellow American ofthe Association for the Trent University. anthropologyand from Heisa Mellon University aBScinpsychology in1985,and his doctorate Carnegie incognitive psychology from University ofCalifornia, Berkeley, Hereceived USA. Professor School inthe ofEducation atthe Palothe Alto Research Center was he and a foraging, Previously things. other among was he at EFSA JOURNAL |SUPPLEMENT ,Florida Institute for HumanandMachine sense making, information and applications indigitalhealth, computer interaction, with intelligence, human– and cognitive science, artificial His research involves amixof MachineHuman and Cognition. InstituteScientist atthe for Peter Pirolli isaSeniorResearch Lazaros Tossounidis to promote technology minimiseitsrisks and Open Source Software paradigm: ethics using to show overall the potential perspectives the and presentation anevidence-based adopts approach Addressed to awideinterdisciplinary audience, the transformation ofsociety. from digital the equitablesharingthe ofbenefits as aninspirational moral architecture, warranting driving onlyasthe not force ofinnovation butalso many for and too FOSS long, hasbeenperceived its influence or By momentum. its challenge too today itisimpossibleto underrate itsvalue, ignore more thanthree now decades –to anextent that information ongoing ofthe heart at the for age Free source openand and software (FOSS) hasbeen Aristotle University ofThessaloniki. Faculty the ofScience, from BSc inMathematics –Universitylinguistics Paris VII. Hereceived his Natural Processing Language computational and University Descartes, René (Paris ofAIin and V), MScdegreesholds from inAppliedMathematics a scholarship French ofthe Government. He Universities Paris VII IIIand fieldofAIwith in the Scientific Centre, as and researcher inthe French Before hisEUcareer, Lazaros worked IBM atthe remodel publicsector. the reforms undertaken by consecutive governments to e-government projects context inthe oflarge-scale worked onGreece’s digitalstrategies onmajor and for Administrative Reform e-Governance. and He 2016) Ministry withthe adviser asseniorcabinet (CII). During recent the euro crisis, served(2012– he high-level Committee for Information Technologies European ofthe has beenamember Institutions’ since bodies,and, and that 40EUagencies 2003, CommitteeAdvisory (ICTAC), comprising more founderHe isthe (2003) IT EUagencies ofthe introduction Euro ofthe signinITsystems (1997). by isknown he EUinstitutionsand for world-wide the companies to openstandards insystems support used rolean instrumental inconvincing leading technology field ofsoftware internationalisation. Hehasplayed Europeanthe Commission’s ITenvironment inthe Silicon Valley significant made and contributions to withrepeatedEurope USA, the and working visits to Cedefop. Heworked in closely ITindustry withthe at direction the assuming ITDepartment ofthe renowned for itsopensystems legacy, before European Commission’s internal ITservice of Vocational Training responsibility atDIGIT, the various held he postsof arena. Between 1998, 1988and actively involved EUIT inthe past 30years hasbeen he training.education and For the reference centre for vocational strategy EU’s atthe adviser Lazaros Tossounidis, senior

European Centre for Development

DAY 3 • 20 September 72 evidenceManaging culture ofFOSS may thrive produce and similar attitudesthe idiosyncrasies and underpinning the discussion explores ofthe part arecurrent thesis: Looking beyond software the industry, third the common good. institutional attitude bestinterest isinthe ofthe case for Also, itsadoption. whether, ultimately, this thereobligation to FOSS, isanauthentic support correctness, often ascribed to publicorganisations’ beyond Whether useofFOSS. the political the public bodies’missioncanbebetter served through pastthe Itattempts decades. to answer whether software-enabled work organisation overfrom acknowledges secondThe part lessonslearned the for society the for and economy the atlarge. with technology governance policy and implications operatingand FOSS solutionsare setinperspective considerations key and drivers building inselecting, innovationand responsiveness. Finally, strategic in publicorganisations flexibility at optimalcost, capabilities to reliably complex support processes futurethe ofwork, We etc. highlightFOSS Protection Regulation (GDPR), digitalworkplace, the market, digitalsingle the new the General Data best practices strategic and policy initiatives e.g. organisations including EUbodiesoutlines the A brief overview useofFOSS ofthe inglobal environmentaland crisis. its present relevance inacontext social offinancial, current FOSS potential oftransition atatime and risks are revisited withaview to understand the costs, models, business and modes and benefits big data.Emerging FOSS products, new licensing technologies such asAI,Cloudcomputing and by FOSS today how and they new co-shape looks secondThe part capabilities at the offered oligopolistic competition. marketsopen anti-monopoly fair and anti- ofsharing, openstandards, creation freedom and values such as:inclusive governance, shared concept ofintellectual property articulated around revolutionises and conventional the reframes technological innovation withamoral order that socioeconomic paradigm allieslife-changing synthesisThe illustrates how FOSS the explain itssuccess nature the and ofitsmoral imprint. cultural underpinnings ofFOSS are summarised to technical,The legal,organisational economic, and technologies thathave enableditssteady evolution. informationthe We age. portray FOSS emblematic throughout successive innovation waves shaping development, we review expansion the ofFOSS compiling key events, facts figures and ofits capturing fabric the By spirit and ofFOSS. discussionisdevoted ofthe firstThe part to avoiding costly vendor lock-in. reducehelp risks the ofproprietary solutionsby operate reliably critical applications,to business today’s complex information architectures, to showcase FOSS readiness to effectively support presentation revolves around FOSS maturity. We offered by FOSS today. central The tenet of the EFSA JOURNAL |SUPPLEMENT Bette Meek evidence inhazard risk and assessment Integrating weighting and mechanistic environment to and anequitablesociety. to sustainableeconomic progress, to asafe to selfish, profit-seeking excesses detrimental are conducive to various minimising risks linked argue such time, same thatatthe alternatives for vendors to and savings for customers. We that alsolead to substantialmaterial profits to conventional proprietary ofcompetition models ventures sharing resources, are valid alternatives through partnerships business complementary shared cutting-edge innovation, richly rewarded contributor. Fair recognition and dividends from transparent redistribution ofbenefits to every FOSSthe paradigm ensures anequitableand highly effective compensatory mechanism of surplus never attained proven, The past. inthe to unparalleled levels ofproductivity creating value technology canboostshared, collaborative creation, Taping into FOSS the legacy, today’s software togoods, and reduce help majorrisks for society. the natural resources universally perceived aspublic mitigate risk the ofabusive practices for accessing significant potential ofthe paradigm help to agricultural food and products. We assessthe in research, production dissemination of and ofreplicatingimportance FOSS the paradigm inspired successful projects. We explore huge the variety offieldsinwhich motivationsFOSS have a are thesis the shortlisted from supporting results humanendeavours. inother Examples for Economic Cooperation Development, and the Programme Safety, onChemical Organization the Worldthe Health Organization International organisations including nationalagencies, and in initiatives inthisarea for international havingrisk convened assessment, participated and increase transparency efficiency and in chemical Dr Meekhascontributed to or ledinitiatives to With colleagues withinCanada internationally, and contaminants drinking inairand water contributed to programmes to assesschemical Before Bette thisappointment, and managed Canadian Environmental Protection (CEPA). Act ofExisting assessment the Substances the under programmes atHealth Canada, recently most in ofchemicalmanagement risk assessment has extensive experience conduct inthe and ,University ofOttawa of Ottawa, Canada. She University atthe of Medicine Risk Science Faculty inthe Centre McLaughlin at the for RiskAssessmentChemical Associatethe Director of Bette Meekiscurrently E-mail: [email protected]

DAY 3 • 20 September 73 evidenceManaging various regulatory applicationsfor which different construct such AOP asthe facilitates itsusefor extent ofmechanistic evidence inacoordinated This structured systematic and consideration ofthe weight ofevidence considered. isbeing approachthe to enablequantitationofcomparative reflect their relative and importance extension of considerations have alsobeenrank ordered to for defined the considerations are provided. The associated withhigh,moderate low and confidence analysis. Examples nature ofthe ofdatasets in international for ofaction mode frameworks more recently for applicationto mechanistic data causality tailored inepidemiologicalstudiesand Hill (B/H)considerations introduced to assess is characterised based Bradford onasubsetofthe extent evidence. ofsupporting Weight ofevidence content, including structured ofthe assessment conventions, terminology relevant and information associated Guidance Users and outline Handbook withinanOECD assessment and programme. The usefor their varioussupport applications intesting been formalised inapublicknowledge base to developmentThe description and ofAOPs has tailored, predictive efficient and strategies.testing strategies isalsoanticipated to advance more adverse effects characterised intraditional testing events measured throughput in higher systems to studies inhumans.Linkage ofMIEs early and key toxicity tests observational inanimalsand orclinical including structure activity analysis, invitro assays, abroad range ofsources risk from assessment mechanistic assessing and datainhazard and pathwayThese descriptions facilitate integrating disposition to target the (toxicokinetics metabolism). and consideration chemical-specific ofthe aspects of for hazard characterisation includes additional or disease outcomes. analysis Modeofaction event initiating molecular (the adverse orMIE)and interaction ofachemical target withamolecular chemically key agnostic events between initial the levels ofbiologicalorganisation. AOPs address sequence ofmeasurable key events atdifferent that organise mechanistic knowledge asa pathways (AOP) are conceptually similarconstructs (MOA)Mode ofaction adverse and outcome University ofUtrecht, Netherlands. the of Surrey, the PhDinrisk her UKand from assessment inToxicology University the MSc. from (withdistinction) Dr Meekhasabackground intoxicology receiving her contribution inthisdomain. risk received and assessment several awards for approximately 200 publicationsonchemical predictiveand hasauthored She modelling. pharmacokinetic combined modelling, exposures adjustment specific factors, physiologically based weight ofevidence, chemical- ofaction, mode included development the to assess offrameworks of France (ANSES).Areas ofcontribution have Environmental Occupational and Health Safety and Joint Research Centre Agency the and for Food, US Environmental Protection Agency, European the EFSA JOURNAL |SUPPLEMENT Wim Van Criekinge Foodomics 2.0 Kathleen Marchal omics data Network-based integration ofmolecular personalized nutrition Keywords: bigdata,bioinformatics, nutri(epi)genetics, ’omics, approach facilitating applicationwillbeaddressed. basedneed, oncritical ofthe datagaps.Aspects focuses research to efforts specific meet regulatory consideration early inAOP development also degrees ofconfidence are required. Coordinated getting ready for personalised nutrition. food sciences willbepresented asFoodomics 2.0 is (near) future profiling applicationsofmolecular in nutrition health. and Aplethora ofcurrent and interesting questionsaround butnon-trivial bottleneck isourability to formulate realistic, intelligence. artificial and Inmany ways ourbiggest technology) through statistics/machine learning ICT (computer science &database ranging from evolved adopted and insights/methods fields from downstream the addition, (big)dataanalysis had currently available atanunprecedented scale.In past years. Especially characterisation molecular is technologies have significantupgrades had the Foodomics 2.0 iswarranted underlying asallofthe well-being,consumer’s health knowledge’. and of advanced ’omics technologies to improve domains through integration applicationand the food thatstudiesthe discipline nutrition and Foodomicsago as adecade ‘a isdefined Devgen, MDxHealth. and Genohm of different successful biotech companies including degree Hewas inMolecularBiology1998. founder Belgium,whereGhent, alsoearned he hisPhD University the of from Engineer 1994 asaChemical Wim Van Criekinge graduated in high-throughput applications. incombinationparticularly with integration analysis, and are bioinformatics, data- Professor Wim Van Criekinge) (founded chaired and by coreThe competences ofBIOBIX Professor Wim Van Criekinge: focuses ondeveloping University.Ghent Herlaboratory Technology (IDLab, IMEC) at of InformationDepartment Bioinformatics atthe and Biotechnology and ofPlant Department the Kathleen Marchal isProfessor at ,University ofLeuven ,GhentUniversity

DAY 3 • 20 September 74 evidenceManaging Elisabeth Waigmann on ’omics inrisk assessment EFSA’sOutcomes Scientific from Colloquium antibiotic resistance development. to unveil mechanisms molecular the thatresult in used to efficiency assessthe ofdrug responses or show, for instance, how analysis canbe cohort problems. statisticallyill-defined solving We will why network are models relevant particularly when integrate heterogeneous ’omics indicate dataand interaction networks, provide anintuitive way to we willshow how network built models, onprior generatedhouse datasets.Inthispresentation data, butalsoasascaffold to analyse own in- networks onlybeusedto cannot visualisebiological known onanorganism ofinterest. prior These of summarising allavailable information molecular between provide nodes, the acomprehensive way metabolites, interactions edgesthe and etc., biological entitiessuch products, gene asgenes, Interaction networks inwhich represent nodes genotype–phenotype mapping. useofnetworkbeen inthe for methods integrative interpretation. Since 2013 group’s the interest has network inference, network-based and data development for ofmethods motif-detection, group’sThe research hascontributed to the data. genetics interpretationand ofsystems systems biologyand computational for methods analysis, the integration temporal spatial and expression and ofgenes provide significant bodiesofinformation on of anorganism. Transcriptomics proteomics and analysis ofentire orcomponent sequences genome inanorganism.molecules canfacilitate Genomics relationshipsand oflarge setsofdifferent types of ’Omics isusedto characterise roles the quantify and availabilitythe ofvast data. ofanalytical amounts for applications inscientific research led and to technologies) upnew hasopened possibilities (designatedmetabolomics collectively as’omics transcriptomics,in genomics, proteomics and In recent years development the ofinnovative tools University the ofVienna. biology from biology, cell ahabilitationinmolecular holds and experience areas inthe cell and ofbiochemistry Universitythe ofVienna. hasextensive She teaching biochemistry, from hasPhDinbiochemistry and Master’s degree withamajorin inchemistry EFSA JOURNAL |SUPPLEMENT Biocentre. a Elisabethholds Laboratories Vienna atthe lecturer MaxFPerutz atthe research group leader and University ofCalifornia, and doctoral researcher atthe was she EFSA in2008, post- EFSA’s Before GMOUnit. joining Elisabeth Waigmann ishead of

European Food Safety Authority Igor Linkov data integration From ofevidence” “weight to quantitative Key words: large datasets,‘omics, risk assessment efsa.2014.3638 chemicals. EFSA Journal 2014;12(4):3638, 87pp. doi:10.2903/j. methodologies andtools for humanhazard assessmentof EFSA (European Food Safety Authority), Modern 2014. References Katrina restoration Sandy and project )and needs analysis) to highlycomplex sites (e.g. Hudson River, analysis, probabilistic portfolio risk assessment, toolsdecision-analytical (e.g. risk-based decision and modelling application ofstate-of-the-science analysis .Many ofhisprojects have included the life cycleassessment, decision and assessment during 2018 onEFSA’s webpage. outcomes colloquium ofthe willbepublished feed products. Anevent summarising report the ’omics tools risk inthe offood assessment and risk assessors process inthe ofincorporating outcomeThe ofthiscolloquium intends to support environmentaland risk assessment. useof’omics the GM plantsand for toxicological formetabolomics comparative the of assessment are: inmicrobial genomics strain characterisation, scientificsafety the support evaluation. These topics which EFSA intends to exploit ’omics datasetsto colloquiumthe have focused onasetoftopics for concrete path Discussionsin ofimplementation. approaches towards hasbuilt and further a tools remit withinthe ofEFSA’s risk assessment integration ofdatasetsproduced viaspecific ’omics colloquiumThe hasexplored for opportunities the http://www.efsa.europa.eu/en/events/event/180424–0). 2018 (for programme presentations and see has taken place inBerlin, Germany on24–25 April next and steps’ state-of-the-art assessment: that EFSA’s 24th Scientific ‘’Omics in risk Colloquium on 2014). Thisprocesssafety hascontinued (EFSA, with tools risk inthe related assessment to food feed and EFSA started useof’omics the mapping In 2014, factors e.g. stressors. status ofanorganism ofexternal impact onthe and provide valuable information functional onthe interpretation integration and of’omics datacan capture datafor alarge poolofmetabolites. The products,gene respectively, whilemetabolomics

Adjunct Professor atCarnegie MellonUniversity advanced ofrisk method projectsmanagement utilizing risk and assessments multiplemanaged risk Mellon University. DrLinkov has ProfessorAdjunct atCarnegie Army Corps of Engineers is and Decision Science Team US atthe Dr Linkov leads Riskand the

DAY 3 • 20 September 75 evidenceManaging comparability across WoE ongoing efforts. standardisation to establishconsistency and successful applicationofWoE to food safety requires summarised inthispresentation. Iwillargue that relatedand areas have beenreported will be and for methods applications ofthese food safety that have beenmushrooming recently. Multiple by recent WoE recommendations approaches and are methods all the captured to varyingdegrees decision analysis (MCDA) Bayesian and methods, wayall the through to quantitative multiple-criteria evidencelisting bestprofessional and judgement, relianceand From onjudgement. commonly used toolsand withvarying degree ofquantitative rigour belief. Ithasevolved‘posterior’ inmultiple methods evaluation ofinformation orevidence to achieve a hypothesis are aparticular against updated after beliefsfor or statistical approach inwhich ‘prior’ processes follow should aninherently Bayesian science. 1960s,itwas Inthe proposed thatWoE have advanced development withthe ofstatistical conclusion. Contemporary WoE methodologies integrates ofevidence lines individual to form a by means ofqualitative orquantitative methods, Weight ofevidence (WoE) isanapproach that, 2019the SRAWorld Congress onRisk. Initiative. Heleads Programme the Committee for representative NationalNanotechnology inthe for Advancement the ofScience. HeisArmy Society for RiskAnalysis American and Association Risk Analysis (SRA).HeisElected Fellow withthe Society the for contribution to RiskAnalysis from 2005and Chauncey Starr Award for exceptional recipientthe 2014 ofthe Practitioner Outstanding Army for medals Heis civilianservice. outstanding committee member. DrLinkov hasreceived three international Heserved asEPA agencies. SAB DOD, NSF, USand other EUand DHS, FDA, served onmany review panels for EPA, advisory and reviewed papers bookchapters. and DrLinkov has analysis, including 20 books over and 300peer- on environmental policy, risk and modelling, Safety Commission. DrLinkov widely haspublished including USEPE, FDA Consumer and Product toxicityand for assessment several agencies, development ofcomputational tools for exposure Adverse Outcome Pathways. Hesupports Weight ofEvidence techniques for assessing decisionfusion,includinguse ofdataand useof the civiliansettings.and Heleads several onthe efforts synthetic biology, additive manufacturing inmilitary projects onevaluation useofnanotechnology, ofthe currently basic appliedresearch and supports (e.g. bioinformatics, stakeholder He engagement). EFSA JOURNAL |SUPPLEMENT Holger Schünemann people oriented. passion for patient care ensures and hisresearch is anactiveMaintaining clinical practice fulfils his (www.decide-collaboration.eu).frameworks guidecheck.html) GRADEevidence and to decision checklistguideline (heigrade.mcmaster.ca/ development tool (www.gradepro.org), the researchers clinicians and through guideline the also focuses onpractical applicationofhiswork by societies for programmes. guideline their Hiswork governmental organisations professional and toHe isanadviser ministries ofhealth, other formethods WHO development guideline in2006. was he and akey contributor to revised the for WHO the numerous and professional societies numerous highprofile guideline includingpanels, Board ofTrustees. Hehasledorparticipated in International Guidelines ofthe member Network making, director the ofCochrane Canada, a collaborating centre for evidence informed policy- co-director World ofthe Health Organization (WHO) advancementand ofevidence Heis assessment. itsspiritdisseminating ofcollaboration, openness majorresponsibility hashad and name for GRADE working group for which coined he the (www.webometrics.info).times ofthe Heisco-chair cited 1,500most the isamong and scientistsofall h-index of123/85 (googlescholar/web ofscience) across since allscientificdisciplines 2015 hasan and ofcurrentscientific minds times Reuters)(Thomson hasbeenlistedhe influential3,000 most the among contributed to over 600peer-reviewed publications, preventiveepidemiology and Having medicine. New York, Hetrained ininternal USA. medicine, Hannover University the and atBuffalo (UB),State of ofPhysiologyDepartment MedicalSchool atthe of biology(post-doc) molecular and inthe nutritional epidemiology (PhD) nutritional epidemiology(PhD) in studentand medical physiology (Dr.med.) asa career inrespiratory exercise and University. Hebeganhisresearch atMcMaster Impact and Research Evidence, Methods, ofHealth Department of the Dr HolgerSchünemann ischair ,McMaster University

DAY 3 • 20 September 76 Envisioning future expertise ofthe the of the futureof the Envisioning expertise the Alison Brimelow CHAIRS expertise forand future. the relevant appropriate and methodologies with society. Thiswillprovide uswith international cooperation, working and across value added the disciplines, of future such ofworking importance asthe ingredients for asuccessful recipe for the developments key discussthe and canrespondagencies to future sessionwilllookathowThe regulatory environment. the humans, animalsand to ensure they cancontinue to protect advances social scientific and intoaccount scientific organisationsneed to take these responses. Regulatory and agencies Complex challenges callfor multiple evidence. greater role production inthe ofscientific predictable society and isplaying a futureneeds are scientific not always Science isadvancing faster thanever, Patent Office and Science.and In2005 was she appointed Commander has alsobeenawarded doctorates honorary inLaw University the ofEast She Anglia. adegreeholds from attended UK.She the USSR and schools USA, inthe Alison Brimelow was born inHavana in1949 and into copyright digitaleconomy. the and Committee ofCREATe, UKcentre the for research charities chaired and Programme the Advisory In retirement, isorhasbeenatrustee she ofseveral concernedposts, mostly withpolicy EU. inthe (DTI), whereIndustry worked she inavariety of later transferred to ofTrade Department the and EFSA JOURNAL |SUPPLEMENT ,Former President oftheEuropean Diplomatic Service in1973Diplomatic Service and British the joined She 2004–2007. from elect servedaspresident- she that, 2010.served untilJune Before Patent Office inJuly 2007 and President European ofthe Alison Brimelow took office as Federica Barrucci RAPPORTEURS Selomey Yamadjako statistics both from the University the ofPadua. statistics bothfrom degree economics instatisticsand aPhDin and manyscientists and others. hasaMaster’s She communicationepidemiologists, mathematicians, microbiologists, chemists, veterinarians, projects,multidisciplinary involving food more than10years ofexperience inworking on Zooprofilattico Sperimentale delle Venezie. has She ofIstituto RiskAnalysisand Department Previously, Federica worked PublicHealth atthe HEC Paris.consulting coaching and for change from 1 Panthéon-Sorbonne, anExecutive and Master in Université the Master degree Paris, inEconomics from Operationsand inTogo Tunisia. and a holds She Federal RepublicofGermany. received Grosses the Bundesverdienstkreuz ofthe Orderof the British ofthe Empire in2011 and she served asDirector ofProgramme Programme, where also she Nations Development years were United spentatthe experience which among 13 20 years ofprofessional Selomey hasoverDepartment. EFSA’s Services Business Selomey Yamadjako ishead of methodologies and tools. and methodologies risk guidance, assessment reviewand ofevidence-based development, implementation the where supports she Unit, Support Methodological EFSA’s Assessment and working asascientificofficer at Federica Barrucci isastatistician ,European Food Safety Authority ,European Food Safety Authority

DAY 3 • 20 September 77 Envisioning future expertise ofthe the Svetla Naydenova George Kass Lucia deLuca is a certified is acertified coach career and counsellor. Valley Thames administration University, from and lead. Svetla aMaster’s holds degree inbusiness manager,acquisition talent and manager staffing literature.and Lucia aMaster’s holds degree inmodern languages lectureran academic workshop and moderator. consultant marketing and Lucia as alsoacts expert. European relations media lobbying specialist, forengagement 4years. Previously, worked she asa design ofEFSA’s new approach towards stakeholder stakeholdermanaged relations coordinated and the deputy head Press ofthe Office. Lucia also communications strategy. In2007, became she contributed to development the ofEFSA’s risk Since has she Lucia EFSA joined in2004, EFSA JOURNAL |SUPPLEMENT ,European Food Safety Authority ,European Food Safety Authority i.e. leadership development various roles inhumanresources, privatethe sector where held she Svetla worked EFSA, joining in Solutions Team Before atEFSA. Development Learning and current role leads she Talent the human resources inher and Svetla Naydenova works in Seebiography p.27 communication expert atEFSA. global cooperation and relations. Currently, Lucia isa media and engagement communications, stakeholder than 16years ofexperience inrisk affairs professional withmore communication public and Lucia deLuca isa ,European Food Safety Authority Ciarán McGinley to embrace future the to your manage beready and business way others, the re-thinking Learning from SPEAKERS future beprepared and needs for them?’ anticipate regulatory ‘the risk industry’ assessment be kept by inmind regulatory agencies? How can environment?the Are there any key to elements systems atprotecting aimed humans, animalsand regulatorywill help science cornerstone beatthe of withincreasingand speed,which success factors many contextual drivers changing time same atthe How dothey navigate thiscomplexity? With so which willbeessential? human capitalelements How dothey decidewhich expertise isrequired and others successfully planinsuch anenvironment? innovativeuncertain, fullofambiguity. and How do We live inaworld thatisincreasingly turbulent, Bristol. University the of Aeronautical Engineering from receivedIn 1981he aBachelor ofScience (Hons)in HEC-Paris. Master Administration ofBusiness from Education: Since 1997 Ciarán a(bi-lingual) hasheld French, Dutch German. and tongue, mother English Languages: verygood and safety areas. to scenarios construction mining, inthe food and UK Health Safety and Board more and, recently, scenarios jointlycarried the EDFand outwithShell, Patenting, hascontributed he to RiskWorld the range ofindustries topics. and to Inaddition Global withScenariodecades across Planning awide Ciarán hasextensive experience spanning two of Global Patenting. set-upand acclaimed the Scenarios for Future the initiatedfunction, OECD the working relationship EPO, atthe time created he ChiefEconomist the process operationally economically. and During his comprehensive understanding global ofthe patent Ciarán isregarded ashaving auniqueand operational units. positions, aswell incharge asbeing ofmajor where awiderange held he (EPO), ofseniorBoard with every President European ofthe Patent Office Intellectual Property worked and directly and under ,NormannPartners focused for 35 years on NormannPartners, Ciarán 2017.January Before joining NormannPartners since a SeniorAssociate at Ciarán McGinley hasbeen normannpartners.com Email: ciaran.mginley@

DAY 3 • 20 September 78 Envisioning future expertise ofthe the Anna Noel-Storr Dealing withanew kind ofteam: crowd The Matthew Wood scientific evidence: Amust? Develop new approaches to useoffuture the This work involves development the ofacrowd initiative Changer Game calledCochrane Crowd. currently leads acomponent ofCochrane’s first review production evidence and synthesis. She of crowdsourcing citizen and science insystematic hasledanumberofinitiativesshe exploring role the CChalmers Thomas the award in2013. Since then, Blazers study, ledby for Annaand which won she evidence production. Trial Thisbeganwiththe ofcrowdsourcingimplementation inhealth recognised asauthoritative legitimate. and scientific bodieshow and they can get good science applicability typology ofthe inthinking about match different types wider the and ofagencies, approaches to entrepreneurial being might strategies. ways Itwilldiscussthe inwhich different entrepreneurial their and agencies EU scientific Political Research, which atypology establishes of study to European inthe bepublished Journal of aforthcoming presentation willdiscuss results from remit whileothers have veryspecifictasks. This salient whileothers are have some and not, awide different levels ofresources, are some politically as ascientificbody. Different scientific bodies have however, bestways aboutthe to beentrepreneurial toneed beentrepreneurial. We know relatively little, legitimacy.and words, Inother scientificbodies making sure goodscientific evidence getstraction at conferences workshops, and networking and withrelevantengagement stakeholders inperson, merely amatter of‘communication’, butalsoof reputation audiences? their among Thisisnot authoritative? How mightthey establishagood work. Dothey evidence seetheir asmore orless stakeholders widerpublicview the and their EFSA JOURNAL |SUPPLEMENT ,University ofSheffield ,University ofOxford development and a leading role inthe During hasplayed she thattime based University atthe ofOxford. Cognitive Improvement Group Cochrane and Dementia Information Specialistfor the Cochrane since 2008 asan Anna Noel-Storr hasworked for toneed beattentive to how Scientific bodieslike EFSA agencies. stakeholder by engagement EU Council focuses onexpertise and Economic SocialResearch and current research by funded the Universitythe His ofSheffield. Matthew Wood isalecturer at the citizenthe organisation. the and welldone itbrings awealth ofadvantages to both routines. Citizen science aneasy isnot optionbut provided training material for machine learning before done datasets onascalenot which has Ithasalsogeneratedeffort. large, highquality its expert community through better useof human effectively hasenabledCochrane to better support collective accuracy. acitizen Using science approach taskscan docertain to averyhighdegree of involved withlittle that, and prior orno experience, Our experience hasshown thatpeoplewant to be playand acrucial role inevidence production. offers contributors achance to getinvolved, learn delugeofinformationthe produced inaway that ofCochrane’s part established to effort manage want to learn. ofcontribution Thismodel isnow an are thatpeoplewant to Cochrane, help people and motivations Main specificityfor involvement is99%. have shown crowd sensitivity crowd and is99.1%, Performance evaluations to assesscrowd accuracy for Cochrane’s Central Register ofControlled Trials. ofrandomisedreports trials have beenidentified classifications have around and beenmade, 70,000 more than150countries. 2millionindividual Almost community comprises over 9000contributors from displayed. To date, (May 2018) Cochrane the Crowd level ofa full paper is inwhich oraportion awhole abstract to orannotate, classify full-text oratthe in which acontributor ispresented withatitleand ontology. microtasks The are at‘citation either level’ (Population; Intervention; Comparator; Outcome) evidence describe then and itaccording to aPICO range ofmicrotasks which to help health identify Crowd was launched inMay Itnow 2016. a hosts unlock milestone rewards new and tasks. Cochrane or diabetes, ascontributors and progress, they in topic areas ofinterest to such them dementia performance indetail.They canchoose to work they oroffline; online canviewactivity their and collective decisionmaking. Contributors canwork agreementand algorithms ensure help accurate health evidence. Brief interactive training modules to dive into tasks needed thatcapture describe and health research. platform The enablescontributors microtasks, to designed describe and identify help science platform thatoffers contributors arange of Cochrane Crowd (crowd.cochrane.org) isacitizen domainssuchother asastronomy ecology. and have beenshown to beextremely effective in inawayand thatisflexible. Citizen sciencemodels an interest inhealth to contribute meaningfully ofcontributiona model thatenablesanyone with to information the manage overload. Italsocreates role to hasanimportant activities, play inhelping volunteers willing engaging inscientific research exponentially, citizen science, process the of At research when atime outputisexpanding Cochrane systematic reviews. exceptionallyon the highquality expected of review production process any without compromise enhance Cochrane’s content speedupthe and microtasks to dive into, allofwhich are to designed platform offering contributors willing arange of

DAY 3 • 20 September 79 Envisioning future expertise ofthe the Hilary Hanahoe Hilary enhance responsiveness) to role(the ofcommunities infrastructure and moreBuilding bridges lesswalls and methodologies tomethodologies enhance responsiveness. way to relevant implement appropriate and tackle grand societalchallenges isanexcellent collaboratingand globally to enhance society and unique example ofhow working across disciplines today.landscape Research The DataAlliance isa geographical challenges thatform ofthe part multi the mind aswell cross- and disciplinary as solutions thatare urgently bearing needed in groundon the propose deliver and technical the is abottom-up organisation, words inother those which we build.RDA fact isuniqueinthe thatit balance non-profit and are the upon foundations harmonisation, consensus, community-driven, principlessolutions. Ourguiding ofopenness, increasing urgent and for needs datamanagement they are intoday’s fundamental ofever landscape learned thatbridges are built not inaday but countriesdisciplines, technologies. and We have 2013, RDA bridges these hasbeenbuilding across to address grand the challenges ofsociety. Since data across technologies, countries and disciplines vision ofresearchers innovators and openlysharing world-wide working together to achieve acollective over volunteer 1356,900 countries members from reuse ofresearch RDA data.The upofover ismade technicaland bridges thatenablesharing and ResearchThe DataAlliance (RDA) social buildsthe DecemberEurope 2014.). Report, data canyieldknowledge, growth’ jobsand RDA DataHarvest: How sharing researchal. (2014) ‘The (e.g. H.et Hanahoe, research e-infrastructures and many fieldofdata, publicationsinthe and reports outreachand strategies. hasedited She written and communication platform communications and user-centric ofthe implementation delivery and the specificallyin development datainfrastructures and hasconsiderableShe experience incommunity Europe. recommendations asICT technical specificationsin process the managed for recognition the ofRDA RDA global secretariat. Inrecent years, hasalso she Communications for Manager the Plenary and coordinatorthe RDA ofthe Europe initiative, the EFSA JOURNAL |SUPPLEMENT ,Research Data Alliance within the alliance,within the including covered amultiple ofroles havingin February 2018, Research DataAlliance (RDA) GeneralSecretary ofthe was Hanahoe Hilary appointed Alliance General,Secretary Research Data Kaoruko Tachibana assessment collaboration towards better humanhealth risk value added The ofinternational inter-sectoral and reliable efficient and risk assessment. addressing ourcommon challenges towards more in making gooduseofourexisting knowledge for international collaboration cross-disciplinary and value added This talkwillhighlightthe of datapropertyand management. common basis ofunderstanding ondataeligibility databases isthatwe buildtogether should a premisethat the for meaningful integration of To make astep we further, also bereminded should in food-related materials. community to better understand humanrelevance could infood potentially ourefforts safety support been started inhumanpharmaceutical community, example, reuse ofexisting database thathasalready humanrelevance. and about ModeofActions For overcoming data gaps,understanding more clearly tackle withourcommon challenges, such as whichof methodologies, would enable usto better different sectors could facilitate development the food safety regulatory orlearning agencies from Data-sharing ormutualdatareference withdifferent of humanrelevance ofanimaltoxicological experiments. risk through assessment amore precise understanding ofourkeyOne challenges isto improve humanhealth workassessment inFood Safety Commission ofJapan. Protecting publichealth ultimate isthe purpose ofourrisk Development StudiesinGeneva, Switzerland. Graduate the Institute ofInternational from and degree inInternational Policymaking Negotiationand London School ofEconomics aMaster’s UK;and inthe London School ofHygiene Tropical and and Medicine the in Health Policy Financing and Planning from received two post-graduate degrees: aMaster’s degree AIDS response monitoring evaluation. and has She UNAIDS headquarter for asasenioradviser global the communication collaboration, and aswell asat States WHO the to and departments facilitate headquarters where Member liaisedwiththe she international worked she civilservant, atWHO strengthening international and cooperation. As an positions such ashealthhealth financing, system contributed to developing health policiesindifferent Japan in2000 officer, asamedical where had she ofHealth, Ministry the joined Welfare and Labour of DrTachibana,methodologies. aphysician by training, expert working group onnew risk assessment leadership role in supporting the leadership the role insupporting hazards. isalsotaking She a on chemical ormicrobiological different risk activities assessment cross-cutting perspectives across Commission ofJapan, providing Coordination Food atthe Safety Director ofRiskAssessment Dr Kaoruko Tachibana iscurrently

, Food Safety Commission ofJapan

DAY 3 • 20 September 80 Envisioning future expertise ofthe the Ian Cotgreave responding to future challenges factor “C” ofthe when importance The illustrate current the conundrum, lecture the will required to perform thisataregulatory level. To of skill entirely ofthem sets,some new to area, the require a commensurate combinations shiftinthe are utilisedinquantitative risk will assessment New Assessmentincluding Methods, so-called different sources, by manner in the which datafrom risk Societalcallsfor assessments. aparadigm shift currently individuals those conducting regulatory considerableis placing contemporary on demands available for predicting hazard risk quantifying and contentthe context and knowledge ofthe base enormousThe pace ofdevelopment ofboth journals) of mechanism-based risk assessment. experience (circa 150publicationsinpeerreviewed diseaseand Ianhasmany modelling. years of alternative inchemical methods risk assessment dealingpanel, ESAC, withEuropean validation of EU Commissions EURL-ECVAMs advisory scientific FromENABLE. 2018 ofthe hasalsobeenamember currently IMIantibioticprogram inthe apartner cell-based for models predictive toxicology. Ianis government SC4SM atstem bothaimed project, STEMBANCC programme, aswell UK asthe Innovativethe Initiative Medicines (IMI) program, EuToxRisk. Ianwas alsoactive ininitiating SEURAT-1 isaPI and follow-up inthe H2020 was Board Co-Chair Scientific ofthe Advisory of From 2009–2014. itsinception, Ian committee from Science Research Councils M3Rresearch grant More recently, Ianwas Swedish ofthe amember 2005–2008. ofAgriculture Department the from Swedish(CFN), the AnimalProtection Agency, and Central Committee for Alternatives to Animals 2002–2004 Chairman the and Swedish ofthe Swedish(CFN), the AnimalProtection Agency from Central Committee for Alternatives to Animals 2001–2003, Swedish ofthe amember agency from Committee Swedish ofthe MedicinalProtection 1997–2001, was Medicinal ofthe amember from Board Swedish ofthe Society ofToxicology (SFT) Ianwas 2014. previously ofthe amember from Sciences Research Center (Swetox; www.swetox.se) Development Swedish withinthe Toxicology 2013and Director and ofStrategic Scientific Molecular Toxicology atAstraZeneca between 2004 graduate level. positionsinclude Other Director of programmes undergraduate atthe post- and responsibility for toxicology teaching/training Institute since where 2002, alsohad he EFSA JOURNAL |SUPPLEMENT ,Swetox of Toxicology Karolinska atthe Sweden. IanhasbeenProfessor Karolinskathe Institute in positionswithin junior academic several and in drugmetabolism, Hospital MedicalSchool London StMary’s with aPhDfrom resident ofSweden since 1984, Ian Cotgreave hasbeena John Palmer set ofinformation develop new capabilities to validate abroader citizenUsing science platforms how and to the dynamic naturethe collective and ofindividual It requires attention to socialscience to and to problems ofdata quality effort. sampling and our work innew ways. Itrequires careful attention however, requires thinking organising aboutand addressing problems the future. ofthe this, Doing perspectives tools and that willbecrucialfor science, researchers and agencies cangain new society. Byembracing paradigm the ofcitizen professional scientistsbutdistributed throughout knowledge expertise are and limited not to temporal scales.They require recognition that implemented across multiple geographic and increasingly require solutionsthatcanbe problemsThe regulatory confront agencies of Appeals for Second the Circuit. mediator astaffattorney and for USCourt the supervisor as alaw clerk to JudgeRichard JCardamone, asa and Refugees inKosovo Montenegro. and Hehasalsoserved as aprotection officer UNHigh for the Commissioner for projects inBosnia,Albania, Kosovo, and hasworked and toIn addition hisresearch, refugee hasmanaged he relief 2003), demography and (PhD, Princeton University, 2013). Cornell(BS, University, 1997), law (JD, Cornell University, (GRITIM). John’s training isinacombination ofecology Interdisciplinary Research Group onImmigration Sociodemography Research Group (DemoSoc) the and segregation, disease and ecology inthe related to humanmobility migration, and social questions arising indemography, law, publicpolicy and to ensure coordinated changes timely and strategic collaborations between allaffected parties to new concepts, practices possibilitiesand and courage allparties, to beopen commitment from intelligence (AI).Thiscoordination willrequire quantitation ofuncertainty useofartificial the and computational techniques in‘bigdata’ analysis, continued professional educationin,for example, of toxicologists level, atanacademic aswell as denovoon the generation’ training ‘next ofthe in society willbeconsidered. Focus here willbe with competence development maintenance and Concomitantly, for demands the coordinating this itssuccessor,and EU-ToxRisk the program. SEURAT-1 the risk from assessment program developmentmethod qualification and for human consider scientific experiencenew in assessment ,Pompeu Fabra University mosquitoes. At UPF works he on disease-vector managing and citizen science system for studying anexpert-validatedMosquito Alert, afoundingand of member Universitat Pompeu Fabra (UPF) Political SocialSciences and at professor of Department inthe John Palmer isatenure-track

DAY 3 • 20 September 81 Envisioning future expertise ofthe the Standards Agency Alisdair Wotherspoon zzzz Collaboration -theagonyandecstasy ongoing initiativesaroundtheworld. offering practicallessonsandadvicefrom along withthepotentialthatcitizenscienceholds, behaviour. Thistalkwilladdressthesechallenges • • • • • • career including: experience atnational/international level over compare-europe.eu )Significant representational H2020 the and project funded COMPARE (www. Learning (IFSTAL )initiative (www.ifstal.ac.uk ) Innovativethe Food Systems Teaching and Foundation; groups for Memberof advisory Governor Council onthe British ofthe Nutrition chair ofitsScience Committee; Science of Food Science Technology and deputy and EU Commission WG on feed additives and Scienc latter project. ofthe part head international ofthe steering committee for safety quality and focused ERANET, Safefoodera; Wor Cur alternate. UK EFSA F national/international organisations. Dev portfolio. communicated and managed itsevidence around how FSA the prioritised, commissioned, Dev EFSA JOURNAL |SUPPLEMENT • • • •

(www.globalmicrobialidentifier.org ); Globalof the Microbial IdentifierInitiative international organisations. funding FSA r Food Science area; Framework 2014 inAgriculture, Veterinary and impa Group; Programme ofthe member Management UK Global Food Security Programme a and ofth member ofint member rent Elected activities: Fellow Institute ofthe elopment of partnership working ofpartnership elopment with governance ofthe elopment/implementation k package leader food EU FP6funded onthe e lead UKdelegationto ofthe the ct assessorforct Research Excellence esearch contact withnational/ ocal Point Forum EFSA and Advisory for: for: Standards Agency. Responsible Science Food Deliveryatthe Research Coordination/Head of 2016 after 14years asHead of foodin the science area. Retired in public sector, witharound 25years Over 35 years experience UK inthe e cross-government/funder ernational steering committee , FormerlyoftheFood Djien Liem Djien increase preparedness for regulatory agencies Networking asatool to horizon scanthe and required to innovate often methodologies compete potential improvements take resources and time, validation,The acceptance and implementation of effectivefind ways to increasingly work together. measures area inthe offood safety may to need conducting risk informing assessments regulatory To keep upwithdevelopment inscience, agencies scientists, risk managers publicatlarge. inthe and topics creating and confusion undue among divergent views ofdifferent onsimilar agencies knowledge concepts. and Thismay lead to howdata and we innovative implement features, wayin the we interpret weigh and available the chemicals infood. Differences canstillhappen consistent way, for particularly evaluation the of bestavailablethe science inaharmonised and we applyrisk using methodologies, assessment suchagencies asEFSA extent is the to which challenge forAn important risk assessment Utrecht the University.PhD inbiologyfrom University the toxicology ofAmsterdam, hasa and from Master’s degree inenvironmental and chemistry a holds CommitteeCommission’s onFood. Djien Scientific secondment secretariat atthe European ofthe Health Environment. the and In2000, took he upa Contaminants Dutch ofthe NationalInstitute ofPublic key to elements overcoming these. collaborations and to befaced indeveloping fruitful challenges ofthe expertise). Itwillalsohighlightsome of increasingly pressured resources and (bothfunds can bring to allconcerned, least not inefficientuse potential advantages thateffective collaborations complex problems faced. many Itwillhighlightthe delivering and agendas solutionsto impactful the driving force ininforming future shaping and research researchagencies, funders others and canbea will focus onhow collaboration between regulatory earlierheld asacasestudy, in2018, presentation the EFSA the Using RiskAssessment Research Assembly, •

ajw science onpolicy. LinkedIn: https://uk.linkedin.com/in/ international of impact onthe particularly meetings, Regularly in Committee.Management Programmeconformation EUFP6/7 ofthe bioproteins food the and agriculture and ,European Food Safety Authority vited to participate/present atnationaland Department of Industrial ofIndustrial Department beganhiscareer atthe Djien 2018. 2013 until Cooperation from Scientific was lead expert inInternational CommitteeEFSA’s Unitand Scientific EFSAHe joined in2003 ashead of Committee Emerging and Risks Unit. Teamsupport atEFSA’s Scientific Liemleads scientific the Djien

DAY 3 • 20 September 82 Envisioning future expertise ofthe the organisations such asWHO, FAO OECD. and as ajointactivity umbrella the under ofinternational recommend harmonisation to activities beconsidered avoid knowledge duplication,identify gapsand ILMERAC provides to opportunities share work, Through conference physical callsand meetings, formethods risk ofchemicals assessment infood. atdeveloping aimed activities implementing and exchangeand experience planned and onongoing harmonised consistent and way. Participants share available science risk intheir ina assessments can cooperate to ensure thatthey best applythe how, thanks to networking, regulatory agencies (ILMERAC) willbepresented asanexample of on RiskAssessment inFood ofChemicals newThe International LiaisonGroup for Methods programmes. numerous included assessments inourwork to needed experts’ time with the outthe carry EFSA JOURNAL |SUPPLEMENT

DAY 3 • 20 September 83 Staying relevant inachanging world Staying relevant inachanging world feed into EFSA’s Strategy 2027. break-out previous sessionsofthe days will moderated paneldiscussionaswell asthe the Relevant pointsemerging from consequences.these to ensure thatwe are prepared to deal with communication, and assessment how and changes may food impact safety, risk Panellists discusshow willthen such agriculture-food-diet-health spectrum. different environment- ofthe elements Speakers willpresent scenarios addressing societyand mightchange future. inthe This sessionwillexplore how science, food EFSA JOURNAL |SUPPLEMENT Elke Anklam CHAIR Barbara Gallani Yann Devos RAPPORTEURS JRC-Ispra site. IRMM),locatedIHCP and and JRC-Geel atthe Referenceand Material (amerger former ofthe new the and JRCDirectorate F:Health, Consumers Director hasbeenthe she 2016, site JRC-Geel ofthe Measurementsand inGeel,Belgium.Since July Director JRC-Institute ofthe for Reference Materials 2012–July 2016, (IHCP) inIspra, from Italyand JRC-Institute for Health Consumer and Protection (EC-JRC). From was she 2006–2012, Director ofthe European Commission’s JointResearch Centre Germany. Since 1991, hasbeenworking she atthe ,European Food Safety Authority ,JointResearch Centre ,European Food Safety Authority Applied University ofFulda, Teaching Professor atthe Research was Institutionsand a workedshe invarious European University Hamburg, Germany, the PhDfrom her obtaining radiationand chemistry. After specialisation infood, organic Elke with Anklamisachemist, Seebiography p.7 Seebiography p.7

DAY 4 • 21 September 84 Staying relevant inachanging world and Innovation, European Commission John Bell bioeconomy How global drivers of/shaping future the SPEAKERS Ilias Papatryfon Tobin Robinson professional background was (Anglo- inacademia Sea) BlueMedInitiative the and (Mediterranean). His Research Alliance, Bonusprogramme the (Baltic R&I strategies including Atlantic the Ocean Nutritionand Security FOOD2030. Heleads Oceans Food Industries and JointUndertaking Bio-Based EUBioeconomy the 2, Strategy, 3.7 the billioneuro includes Horizon 2020, billionSocietalChallenge 3.8 in new industries. sustainable bio-based This oceans, marine maritime and issuesto investment Universitythe ofMaryland. in marine estuarine environmental sciences from deEducacionNacional hasaPhD and aDistancia, Universidad the in appliedeconomics from Agricultural Research. aMaster’s Iliasholds degree French the Studies and NationalInstitute for Centre Institute ofthe for Prospective Technological worked he EFSA, joining for JointResearch the in corporate monitoring. and planning Before cooperation withMember States moving then and EFSA JOURNAL |SUPPLEMENT ,Directorate-General for Research ,European Food Safety Authority ,European Food Safety Authority agriculture food and systems, Bioeconomy;the from policy programming and across of EUResearch Innovation and investment and implementation leading definition, the Innovation. Heisresponsible for Bioeconomy inDGResearch and Dr JohnBellisDirector for the first area inthe EFSA, ofscientific variousheld positionswithin monitoring quality. and Iliashas organisational performance budgeting, planning, responsibilities instrategic withmain Services, EFSA’s Global Performance Ilias Papatryfon head isacting of Seebiography p.8 Tim Benton futureThe offood: scenarios analyses Key words: bioeconomy, bio-based, biologicalresources, innovation ‘Champion’ UK’s ofthe Global Food Security (GFS) of the planet, remains planet, of the aglobal challenge. sustainable materials energy and limits withinthe world population,whileproviding low-carbon, supply ofbiologicalresources to feed agrowing regions sustainable cities.Asufficientand and bioeconomy across MemberStates, opportunities knowledge through monitoring deploy and investments sectors, inbio-based generate of bioeconomy skills education,upscale and research innovation, and foster development the achieve this,Europe to needs strategic support people’s behaviour, consumption and pattern. To bioeconomy sectors, industries, value chains and drive asystemic change across various the policies, low-carbon society. future The bioeconomy must towards asustainable,circular, zero-waste and UN Agenda 2030, itmustadvance itstransition commitments Paris ofthe Climate agreement and global bioeconomy leadership the meet and If Europe wants to maintainitscurrent nutrition security to and environment. sustainthe renew green and industry, to ensure food and European to agenda create growth, jobsand to niche to economic norm isdelivering and the Europe’s innovative bioeconomy ismoving from College, Oxford University. Ireland’Nationalism inNorthern atStJohn’s completed hisDoctorate (D.Phil.) in‘Cultural was educated atUniversity College Dublinand simplification.Anativeand ofDublin,Ireland,he mainstreaming innovation, investment financial developing Horizon funding and 2020, Research Innovation, and was he responsible for Commissioner Máire on Geoghegan-Quinn Kuneva onConsumer Affairs. As Head ofCabinet to Cabinet to European Commissioner Meglena issues, including bioterrorism. Hewas Head of control, publichealth global and health security responsibility for enlargement, food safety, tobacco Cabinet ofCommissioner David Byrne with accession to EU. the DrBellwas ofthe amember in Central Eastern and Europe, onPoland’s and formerthe Yugoslavia, publicadministration reform assistanceRelations onfinancial programmes in During hisEC career hasworked he inExternal Irish journalism inbusiness Studies)and inLondon. ,University ofLeeds From 2011–2016 was he the Affairs atChathamHouse,UK. Royal Institute ofInternational Resources atthe Department Energy,the Environment and VisitingDistinguished Fellow at Universitythe ofLeeds and Strategic Research Initiatives at Professor Tim Benton isDean of

DAY 4 • 21 September 85 Staying relevant inachanging world Sandra Caldeira Consumer archetypes infuture food systems better futures. present the day totransformation potential from futures, costs their the and barriers benefits and to analyses, different Iwillhighlightsome potential like? Following reviews recent ofsome scenarios system thatdelivers healthy diets,sustainably, look asusual’, be‘business cannot what mightafood Climate agreement, future thatthe offood systems SustainableDevelopmentthe Goals Paris the and growingthe recognition, following launch the of fromagricultural the economy. benefits Given economicthe costs far exceed economic the major contributor to climate change. As such, environmental degradation, including a being fromcreates asignificanteconomic burden costs associated withfood-related ill-health, and rather thanahealthy weight, economic withthe more peopleglobally withanunhealthy weight competition. Ourcurrent food system now leaves liberalised global markets to international support thatcheapnotion food isapublicgood,and We have evolved food systems based onthe food security. contributed to many onfood reports systems and overhas published papers, 150academic and tothem become more resilient. sustainableand He for need the and countries insub-Saharan Africa), local food systems (withafocus UKand onthe Climate. and Land Hiswork focuses onglobal and Climate Change’s onFood, (IPCC’s) SpecialReport Lead Author for Intergovernmental the Panel on Forum’s Food Systems Nutrition and and topic, is anAgenda Steward for World the Economic nutritious sustainableand diets sufficient, for all.He priorities to mitigate challenges the ofproviding analysis horizon and to scanning, research identify food. key The role ofGFS was to undertake systemic councils) withaninterest challenges inthe around devolveddepartments, governments research and UK’sof the publicbodies(government programme, which was amultiagency partnership information oncancer rare and diseases, (iii) and communicable diseases, (ii)improved health This isto include: (i)prevention ofnon- ofassociated implementation the EUlegislation. health-care states inallmember to and facilitate health, to promote excellence equality and of Unit’s missionisto EUpoliciesinpublic support Society DG JointResearch Unitatthe Centre. The EFSA JOURNAL |SUPPLEMENT ,JointResearch Centre as Deputy Head Health ofthe in communicable disease now and prevention ofnon- area inthe manager of Health ever since, first asproject policy area inthe ofPublic been working inscience for Commission in2010 has and Sandra European the joined 10.2787/625130 Future Challenges AndPolicy Preparedness, DOI: JRC101971. Delivering2016. OnEu Food Safety AndNutrition In2050 - Anne-Katrin, Wollgast Jan,Caldeira Franz, Sandra, Ulberth Mylona Kalliopi, Maragkoudakis Petros-Achillefs, Bock Priorities For Foods AndDiets,JRC91330. DOI:10.2788/1395 Franz, Tomorrow’sUlberth 2014. Healthy Society -Research Sandra, Czimbalmos Agnes, Rzychon Malgorzata,Atzel Bela, Bock Anne-Katrin, Maragkoudakis Petros, Wollgast Jan,Caldeira References nutritious fair dietsinasustainableand manner. current futureand consumer choices in safe, healthy, understanding ofafood system thatresponds to basis questionssetthe on these to abetter respond to future needs? Structured reflections priorities redesigning thatneed orprioritisation to regulations, risk strategies assessment orresearch respond to challenges? these Are there policies, societies, governments players and infood systems to these? system the canderive How can from are consumers’ these which and needs challenges consumer other orthe one type dominates. What us to explore how future food systems may if look, our peers. However, scenarios the approach allows contemporary ourfamilies societies,among and consumer types canalready beobserved inour or are very trendy highlytechnological. and These purelyones, thatfollow orthose hedonic strict diets sustainability consumers, minded to price-focused health- or of consumers. range These from developedthe scenarios typical and examples al., 2016). Thispresentation willdescribe of some consumerand roles (Bock Mylonaet etal.,2014; future scenarios, withvery different characteristics Centre (JRC)hasdeveloped several EUfood-related context ofitsforesight work, JointResearch the how choices these affect system the itself. Inthe aspirations, food lifestyle and choices aswell as tois important understand whatshapestheir Consumers are key drivers offood systems; it of future food safety nutrition. and outcome Unit’s ofthe foresight area inthe activities EFSAthe Conference, Sandra willdiscussthe inHeidelbergBiology Organisation (DE).At (EMBO) as aScientific Editor atthe European Molecular professor University atthe ofGenetics ofLisbonand University positionsasaninvited held (USA)and Cambridgeand University (UK)aswell asStanford postdoctoral researcher inLisbonUniversity (PT) Sciences.in Biomedical worked She asa Microbiology inBiotechnology and aswell asaPhD cancer healthcare quality. Sandra degrees holds in

DAY 4 • 21 September 86 Staying relevant inachanging world John C. Mathers John C. futureThe ofresearch inpersonalised nutrition relatively ineffective ithas beenproposed and that However,diet. interventions dietary most are risk ofcommon complex diseases aimsto improve health, somuch public health advice to reduce the Eatingnurture. patterns have amajorinfluence on ofbothnature importance emphasises the and that influence phenotype, includinghealth, growingthe evidence interactions ofdiet–gene explaining inter-individual differences. Inaddition, been much excitement role aboutthe in ofgenes there humangenome, ofthe sequencing has responsible for thisvariation following but, understanding physiological ofthe mechanisms exposure.dietary To date, we have onlyalimited variationindividual inresponse to exactly same the ample evidence thatthere isconsiderable inter- conducted nutritional intervention studiesprovide from well ofthisidea, In support findings nutritional ofeach needs person are alsodifferent. in multiple ways, idea itisabeguiling thatthe next the As each person individual differs from reduce disease. risk the ofAlzheimer’s Newcastle –thataimsto improve lifestyle to and Universities ofEast Birmingham Anglia, and MedEx-UK project –acollaboration between the approaches are investigated alsobeing current inthe behaviour.dietary web-delivered These personalised conventional approach ‘one-size-fits-all’ inimproving nutrition approach ismore effective thanthe countries thattested idea the thatapersonalised Food4Me intervention studyacross seven European JohnMathersage. EUFP7-funded alsoledthe promote better health independence and into old todesigned olderpeopleimprove help lifestyle to and developed piloted and aninternet-based intervention LiveWellthe Programme ofresearch, which influences ultimately, and, cell function health. Heled understand mechanisms the which though nutrition includes tools epigenomics and useofgenomic the to Nutrigenomics Organisation) hisresearch and currently Chair, European ofNuGO(the bowel cancer. Hewas afounding member, is and such disease, asheart diabetes, and dementia influence risks of age-related common diseases interests are inunderstanding how eating patterns Newcastle University. JohnMathers’ majorresearch in Edinburgh University before appointed being to doc atCambridge University aResearch and Fellow Nutrition atCambridge University. Hewas a post- studies inNewcastle University PhDtraining and in University. JohnMathers undertook undergraduate EFSA JOURNAL |SUPPLEMENT ,Newcastle University for Ageing Health, and Newcastle Scientific Director Institute ofthe Nutrition Society former and UK. Heisapast President ofthe atNewcastleMedicine University, Centre Institute inthe ofCellular HumanNutritionthe Research Human Nutrition Director and of John Mathers isProfessor of glycemic responses. Cell, 163,1079–1094. Zeevi D, etal.2015. Personalized nutrition by prediction of Medical Journal,i4707. 354, eightrandomised controlled trials. British datafrom participant systematic review andmeta-analysis of9563individual Livingstone FTO KM,etal.2016. genotype andweight loss: Medical Association, 319, 667–679. DIETFITS randomized clinical trial. Journal oftheAmerican association withgenotype pattern orinsulin secretion: the diet on12-month weight lossinoverweight adults andthe Gardner CD, Effect etal.2018. oflow-fat vs low-carbohydrate Epidemiology, 578–588. 46, European randomized controlled trial. International Journal of health-related theFood4Me behaviour change evidence from Celis-Morales etal.2017. C, Effect ofpersonalized nutrition on Nutrition Society, 74, 130–1308. for more effective behaviour change. Proceedings ofthe Celis-Morales etal.2015. Personalising C, nutritional guidance References improved habitsare inperpetuity. sustained dietary ensure thatadvice isconverted into that and action cultural factors thatinfluence eating patterns to to address psychological, the social,economic and contribution to improving public health, itwillneed However, ifthisresearch isto make asignificant more refined approaches to personalised nutrition. factorsdietary may and provide ascientific basis for inter-individual differences response inthe to specific et al.,2015). Such research potential hasthe to explain as multiple ofgenotype aspects phenotype and (Zeevi effectsthe mediated by gutmicrobiome, the aswell nutrition isnow broadening itsscope to consider for increased adiposity. Research into personalised is justassuccessful risk thatcarry inthose alleles are always not one’s destiny thatweight and loss towishing loseweight asitshows thatone’s genes loss (Gardner etal.,2018). Thisisgood news for those i.e.genes, PPARG, FABP2, ADRB2and onweight that there was effect no ofvariants inthree other intervention studycarried USAfound outinthe loss (Livingstone etal.,2016). Similarly, arecent riskof the allelefor FTO effect no had ofweight about 9,500 we participants, found thatcarriage eightlarge weight lossstudiesinvolving data from it alsomake itmore difficult to lose weight?’. Using risk variant inFTO to helps make peoplefatter, does effect onadiposity sowe asked question‘Ifthe the obesity-associated have gene (FTO) biggest the general population,variants fat inthe massand is influenced make-up. genetic by his/her Inthe it isclear thatanindividual’s risk obese ofbeing world,the prevalence rates ofobesity are rising and (Celis-Morales benefit added no etal., 2017). Around developing personalised the nutrition advice had phenotypic orgenotypic and information in et al.,2017). However, inclusion the ofmore complex in eating behaviour after (Celis-Morales 6months nutrition intervention changes hasbiggersustained advice), peoplerandomised those to apersonalised controlwith the (standardised healthy eating internet-delivered intervention. dietary Compared randomised to offour one treatment groups inan seven countries wereStudy inwhich adults from idea was tested pan-European inthe Food4Me moreand effective (Celis-Morales etal.,2015). This to may individual the bebothmore acceptable personalised approaches intervention thattailorthe

DAY 4 • 21 September 87 Staying relevant inachanging world Katherine McComas recognition, reconciliation rewards and Communication challenges future: ofthe realities canlead to rewards ifcommunicators channels. Recognition reconciliation and ofthese traditional seekers ofinformation, from not and must acknowledge thataudiences are active described how communication took place. Italso isabygoneof messages concept, ifitever truly today mustrecognise that‘controlling’ field the candour, any to effort honest communicate risk beyond control the ofany source. one Inall convincing more and trusted, dueto aspects with aplethora sources ofother thatmay beas scientificauthority,of asingle are competing sought to convince audiences primacy ofthe outdated ofcommunication, models which must reconcile itselfto reality the thatformer, thischallenge,meet effective communication of information aboutany given topic To ofrisk. unparalleled access to ofsources thousands averitablehas opened Pandora’s box, providing group, global societaland levels. Internet The to change, individual, withimplicationsatthe communication haschanged willcontinue and irrefutablethe evidence of landscape thatthe on science society and mustfirst recognise toEfforts address future communication challenges College London, UK. Fall 2017, was she aVisiting Professor atKing’s President-Elect for Society the for RiskAnalysis. In Fellow for Society the for RiskAnalysis, currently and Communication for journal the RiskAnalysis, a Committee.Advisory Area isthe She Editor for Risk CommitteeAdvisory itsBloodProducts and Transmissible Spongiform Encephalopathies network.14-member FDA’s servedonthe She research for educationalactivities and the for which oversaw she coordination the ofSEI Network, National Nanotechnology Infrastructure Issues (SEI)Coordinator for NSF-supported the From 2008–2013, was she Ethical Societaland the ofAgricultureDepartment (USDA), others. among US Food DrugAdministration and (FDA), US and Parks USEnvironmental Service, Protection Agency, by NationalScience the Foundation (NSF), National Risk Communication. Herwork hasbeensupported books, SAGE the including of Handbook co-editing of70+co-author refereed journal two and articles environmental risk or author isthe issues.She surrounding communication aboutscientificand on understanding motivations barriers and Affairs. DrMcComas’ research teaching and focus EFSA JOURNAL |SUPPLEMENT for Grant Land and Engagement Cornell University’s Vice Provost willalsobecome she In July2018, environmental communication. science,specialises inrisk, and University, USAwhere she Communication atCornell Professor of Department ofthe McComasDr Katherine is a A. Renata Clarke PANELLISTS safetyadvice. scientific recognizedand independence FAO’s ofthe food processes to guarantee continued the excellence regular review and ofmethods updating and advicescientific of demands meet the to Codex and programme are delivery of upofthe scaling the Alimentarius Commission. Current priorities ofthat underpins standard the setting work Codex ofthe primarily providesadvice scientific the that Food Safety Scientific Advice, jointlywith WHO, ground. onthe impact FAO The Programme on development maintainsacritical and needs eye on approaches to responding to countries’ capacity emphasises innovation tools inthe the and regulation food and safety quality. and Italso guidance ongoodpractice and management inthe with FAO’s networks ofexperts to generate proven formerThe programme emphasisespartnership FAO Programme ofFood Safety Scientific Advice. communication landscape. how bestto work new the against, with,not will invest resources and time the to understand able to respond to communication challenges profound. Looking towards future, the best those technologies potential their and affordances is people to experience new worlds, listofthese the to realitymanagement, virtual headsets thatallow behaviours, to devices mobile thatmonitor pain to sites socialmedia thatinfluencehealthy are first responders to environmental disasters, creativeand ways. From telepresence robots that options to withaudiences engage inmeaningful oftodaylandscape future the and offers many role communication inunderstanding the risk, to-face interactions willcontinue to play avital values into decisionmaking. whileface- And, audience incorporate and needs stakeholder communication approaches thatrespond to accept thisknowledge more adopt and interactive capacity development the and programme offood safety oversees she Unit, adiverse FAO Food Safety Quality and 20almost years. As Head ofthe FAO onfood safety issuesfor since 2011 hasworked and within Food Safety Quality and Unit Renata Clarke leads FAO the

DAY 4 • 21 September Staying relevant in a changing world

Martin Dermine Michael Scannel

Martin Dermine is a doctor in Michael Scannell is an official of veterinary medicine and holds a the European Commission since PhD in veterinary pathology. He 1991. He is currently Director for joined the Pesticide Action the Food Chain – Stakeholder Network (PAN) Europe in 2012 to and International Relations in work on the toxicity of pesticides the Directorate General for on pollinators, using his expertise Health and Food Safety. He was on honey bees as a beekeeper until recently Director of the since the age of 14. Martin has Food and Veterinary Office which been engaged in EFSA’s work on pesticides and as is responsible for promoting proper enforcement an EFSA stakeholder for many years. Martin is a and compliance with EU requirements on food member of the EFSA Stakeholders’ bureau, safety, animal and plant health in both EU Member representing EU NGOs. He is also involved in the States and third countries. His previous positions EFSA stakeholder discussion group on emerging risks. included chief spokesperson for the EU in the Codex Commission and in the Sanitary and Phytosanitary Committee of the World Trade Organisation Mella Frewen between 2002 and 2010. He also worked from 1995 to 2002 in the private offices of Commissioners, with particular responsibilities in the area of tobacco Director General of control, trade, economic, food safety and animal FoodDrinkEurope, representing health regulatory issues. This period included the Europe’s largest manufacturing BSE and foot and mouth diseases crisis and the industry, since July 2007. creation of a specific Directorate General for Health Protection and of the European Food Safety Mella Frewen’s previous positions Authority. Mr Scannell is Irish and a graduate in include Director for Government economics and politics from University College Dublin. Affairs EMEA at Monsanto, dealing with agricultural biotechnology, conventional agriculture, seeds and agri-chemistry. William Slikker

Before that, she was Director, International Dr William Slikker, Jr is the Relations for Cerestar, then Europe’s biggest starch director of FDA’s National Center producer. From this role and her earlier ones in the for Toxicological Research Ferruzzi and Eridania Bégin-Say Groups, stationed (NCTR). He received his PhD in in Brussels, she has a wide experience of relations Pharmacology and Toxicology with International institutions, with the Institutions from the University of California of the European Union and trade associations at Davis, USA. Dr Slikker holds within the food chain, as well as with the agri-food adjunct professorships in the and non-food, and chemical sectors. Departments of Pediatrics, and Ms Frewen has represented the Food Industry in the Pharmacology/ Toxicology at the University of several EU Commission Advisory Committees and Arkansas for Medical Sciences. He is currently Standing Committees. She is currently a member of associate editor for NeuroToxicology and for the EU Commission’s High Level Steering Board for Experimental Biology and Medicine. He has served the European Innovation Partnership for Agricultural as president of the Academy of Toxicological Productivity and Sustainability, of its High Level Sciences, the Teratology Society and the Society of Platform for the Implementation of the SDGs and of Toxicology. Dr Slikker has co-authored over 350 its Scientific Jury for EUCYS (Competition for Young publications in the areas of transplacental Scientists), among others. She is also member of pharmacokinetics, developmental neurotoxicology, several food industry-related Boards. systems biology, and risk assessment.

At the OECD and FAO, Ms Frewen is Vice President of the Advisory Group for Responsible Business Conduct along Agricultural Supply Chains.

She has worked in the Agri-food sector in Europe for 27 years. She has a Master of Science degree from the National University of Ireland, and completed a post-graduate course at the University of Brussels (ULB). She also holds a Harvard certificate on Agribusiness and an INSEAD certificate on International Operations Management.

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Poster session

Human health relative proportions of the species were used as measure of the individual methylation capacity, i.e. as an estimate of the detoxification efficiency by As- exposed children. 1. Risk assessment of arsenic exposure from gluten-free cereal food in children Genetic markers (SNPs) in genes regulating As with coeliac disease: exposure assessment, methylation and detoxification were investigated to clarify how genetics affects As metabolism and study of urinary metabolic profiles individual susceptibility to iAs in children with CD. and genetic polymorphisms Project Ricerca Finalizzata GR-2011-02349632 supported by the Italian Ministry of Health. AURELI Federica Istituto Superiore di Sanità

Federica Aureli, Francesca Ferraris, Andrea Raggi, Marco 2. Predictive mechanistic in silico Silano, Francesco Cubadda – Istituto Superiore di Sanità- National Institute of Health, Rome, Italy simulations of mixture of azole fungicides Monica Ancinelli, Mariangela Caruso, Cristina Felli, acting on cranio-facial morphogenesis Francesca Ferretti, Andrea Masotti, Valerio Nobili – Bambino Gesù Children’s Hospital-IRCCS, Rome, Italy BATTISTONI Maria Carlo Catassi, Elisa Franceschini, Simona Gatti, Elena Lionetti Università degli Studi di Milano – Università Politécnica delle Marche, Ancona, Italy Ruggiero Francavilla, Maria Elena Tripaldi – University Elena Menegola – Università degli Studi di Milano, of Bari, Bari, Italy. Department of Environmental Science and Policy, Milan, Italy Massimiliano Copetti – Casa Sollievo della Sofferenza- IRCCS, San Giovanni Rotondo (Foggia), Italy Frederic Bois – INERIS, DRC/VIVA/METO, Verneuil-en-Halatte, France In the general population the main source of inorganic arsenic (iAs) is food, with rice playing an important The huge number of combinations of chemical, role depending on consumption figures. Chronic the paucity of efficient test strategies for the risk oral exposure to iAs, depending on its duration and assessment of mixtures, and the increasing societal magnitude, may lead to different types of cancer, skin need to reduce animal testing make the study lesions and other adverse outcomes. Rice is used as of mixtures a very complex issue. Single azole a substitute for wheat in the diet of children affected fungicides, can affect cranio-facial morphogenesis by coeliac disease (CD), a condition caused by an during the early development. Data previously abnormal immune response to gluten. This paediatric obtained in post-implantation rat whole embryo population may have a higher dietary exposure to iAs cultured in vitro described specific teratogenic and might be more vulnerable to iAs toxicity. effects at the branchial structures, while the co- exposure resulted in mixture effects, accounting A multicentric study involving 160 CD and 160 for a common mode of action (MoA) for the azole healthy children aged 3–10 has been launched to fungicides. The proposed MoA for azoles is the test this hypothesis. inhibition of CYP26 enzymes, involved in the retinoic acid (RA) catabolism, with a consequent indirect A Food Frequency Questionnaire was administered increase in the local endogenous concentration of to identify the types and amount of rice and gluten- RA at the branchial apparatus level. With the aim free products eaten by CD children. The selected of investigating this hypothetical mechanism, the products were then characterised for the content specific teratogenic effect of some azole fungicides, of iAs. The iAs intake of CD children was estimated alone or in mixture, has been tested in vitro. Then, combining analytical data and food consumption data were interpreted developing an innovative data. The additional exposure associated to in silico tool, combining in vitro experiments and consumption of gluten-free food is estimated by mathematical and probabilistic modelling of RA considering the ‘cereal grains’ food group from the pathway enzymes. After training with single azoles Italian Total Diet Study for children of the same age. dose–response data, predictive simulations for the Additionally, As in nails was used as a biomarker of mixtures were performed. The model appears to long-term iAs exposure. be reasonably predictive for the mixture effects Urine from children were collected after a 5-day (experimental data and model predictions are in diet with exclusion of food containing (or being promising agreement) confirming the accuracy of metabolised to) DMA and analysed for iAs and the hypothesised pathogenic pathway. In addition, its methylated metabolites, MMA and DMA. The the formation of physiological RA levels in the rat

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embryo hindbrain can be reasonably estimated after 4. Distribution of 35S-labelled azole exposures. This research will provide a better perfluorinated compounds in C57Bl/6 understanding of the toxicity mechanism of single mouse after a short-term dietary and combined chemicals affecting RA (not just azole fungicides), and a predictive tool for human exposure – the main route of exposition risk assessment for all mixtures acting on cranio- of humans facial morphogenesis. Finally, predictive mechanistic simulations of mixture effects, just using dose–response BOGDANSKA Jasna data for single chemicals, will significantly reduce the Ss Cyril and Methodius University of Skopje use of animals in developmental toxicity studies Jasna Bogdanska, Manuchehr Abedi-Valugerdi, Joseph DePierre – Department of Biochemistry and Biophysics, Stockholm University, Sweden 3. Food safety and its regulation practice Maria Sandsrom, Ake Bergman – Environmental in developing countries like Nepal Chemistry Unit, Department of Materials and Environmental Chemistry, Stockholm University Sweden Daniel Borg – Institute of Environmental Medicine, BHATTA Khem Raj Karolinska Institute Stockholm, Sweden St. Xavier’s College Ulrika Bergstrom – Department of Environmental Toxicology, Uppsala University, Sweden Sriniwas Pandey – St. Xavier’s College Stefan Nobel – Department of Molecular Medicine Healthy and safe food is one of the fundamental and Surgery, Section of Integrative Physiology Karolinska rights of the living being. Naturally, food is pure and Institute Stockholm, Sweden safe but during the processing and preparation, it is being adulterated by different means. It is a matter of Perfluorooctanesulfonate (PFOS) has been global concern guaranteeing long-term availability used world-wide for decades due to its unique of safe food. Therefore, different activities including characteristics, but has been withdrawn due to its research, policy development and implementing bioaccumulative and toxic properties. Therefore the food act and food safety have been practised the manufacturers of fluorochemicals started with globally. This paper aims to analyse the safety perfluorobutanesulfonyl fluoride (PFBS) production, concern and the food adulteration in different food which tended to be more rapidly eliminated products like milk oil and water in Nepal. The paper in animals. Due to the limited data of detailed further explains the harmful biological and chemical distribution of PDOS and almost no data of PFBS components that are found in the food and their distribution in experimental animals the present hazard in the human being. It also focuses the study was designed to characterise the tissue functioning of present food act and policies related distribution of both compounds in mice. to the food safety and adulteration in Nepal. The 35S-labelled PFOS and 35S-labelled PFBS were The data obtained from various foods regulating used for dietary exposure of male C57Bl/6 mice for bodies and consumer rights activists were collected 1, 3 and 5 days in a dose(s) of 23 mg/kg/day. After and analysed both qualitatively and quantitatively. treatment the mice were sacrificed, the organs A study shows that the adulteration in the food is were dissected and the detection of the presence of perpetual for sudden benefit besides natural means. radiolabelled chemicals was performed using liquid The results revealed a higher degree of adulteration scintillation counting in a Beckman LS 6000TA Liquid in liquid as compared to solid food. Awareness to scintillation counter. All statistical analyses were producers, traders and consumers in partnership performed using statistical packet Winstat for Excel. with government agencies is to be enhanced. PFOS has been distributed mainly in the liver (40– To assure the quality of food and to mitigate the 50% day one and day 5 respectively) followed by the adulteration, the government has to form and skin (20%), blood (15%), bone (10%), and muscle (10%) implement strong food act and policy along with with a tendency of now saturation (except for the the regular inspection of the industry. bone). PFBS has been mostly recovered in the bone (15–22% on a day 1 and day 5 respectively) followed by the liver (20%), blood (20%), skin (18%) and muscle (13%). There was no saturation of PFBS in bones, in contrast to PFOS, after 5 days of exposure. PFBS distribution in the liver has shown differences in comparison to PFOS showing saturation after 3 and 5 days of exposure. The distribution in other organs of both compounds was similar. We may conclude that the major compartments for both PFOS and PFBS in C57Bl/6 mice are the liver and the bone, followed by blood, skin and muscle. We have demonstrated the presence of PFBS in the examined organs was similar to the PFOS, which should be considered in the future studies. Key words: PFOS, PFBS, Distribution, Dietary exposure.

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5. The exposure to Fipronil within an One significantly to dietary arsenic exposure. In this Health approach study, the occurrence of arsenic was measured in rice and rice-based products intended for toddlers (N = 105). As arsenic toxicity is highly dependent on BRAMBILLA Gianfranco species and oxidative state, not only total arsenic Istituto Superiore di Sanità content, but also species, such as As(III), As(V), Roberto Miniero – Istituto Superiore di Sanità, Rome, Italy MMA(V) and DMA(V), were measured using an ion Paola Roncada – Dipartimento di Scienze Mediche chromatography-inductively coupled plasma-mass Veterinarie, Università degli Studi di Bologna, Bologna, Italy spectroscopy technique. The predominant arsenic Cecilia Testa – Istituto Zooprofilattico Sperimentale della species was As(III), with 60–80% of the total arsenic Sardegna, Sassari, Italy content, followed by DMA(V) and As(V). MMA(V) was measured only at low levels (<3%). Based on Fipronil as a non-competitive blocker of German food consumption VELS data, the iAs γ-aminobutyric acid (GABA)-gated chloride channels exposure for toddlers (1–3 years) was estimated in is a registered insecticide present in pesticide and different scenarios. For ‘only consumers’, rice drinks biocide formulations for the agronomic use and to were the predominant contributor for iAs intake control insects and ecto-parasites in indoor and in in all scenarios followed by rice-based cereals. In pets, respectively. Recently, its off-label use in poultry several scenarios, iAs intake was estimated to be farming determined residues of fipronil and its higher than EFSA’s lower BMDL01 of 0.3 μg kg−1 bw metabolite sulfone in dropped eggs of potential risk day−1 for 1% excess cancer risk, but in no scenario for acute neuro-toxicity in children under a worst- higher than EFSA’s upper BMDL01 of 8 μg kg−1 bw case food intake scenario. Furthermore, the risk day−1. Potential health risks cannot be excluded, in assessment suggest the consideration of aggregate particular for toddlers: (1) with coeliac disease, when exposure from house dust. Vacuum cleaner bags rice and rice-based products are consumed instead of from 176 Italian households indicated a declared gluten-containing cereals; (2) with cows’ milk allergy, for pet’s presence (N = 114 samples) was significantly whom rice drinks replace cows’ milk; (3) vegans, who do associated with a higher fipronil + fipronil sulfone not drink cows’ milk and consume rice drink instead; contamination in dust. Within this context, the 64% and (4) from specific ethnic groups who cover their of samples fell above the reporting limit of 0.01 mg/ carbohydrate needs mainly through rice. Based on the kg, with occurrence descriptors for P50, P75 and P99 study results, the FSVO established recommendations at 0.31, 3.18, and 62.2 mg/kg dry weight, respectively. for the consumption of rice and rice-based products for The identified presence in dust of fipronil desulfinyl parents and their toddlers in Switzerland. as a degradation product was reported to be 10× more active on the GABA type A receptor of vertebrates than fipronil, and would represent an 7. Study the occurrence of acrylamide in opportunity to set toxicity equivalency factors. In this approach, in silico QSAR approaches are envisaged food in comparison with the long-term to refine the uncertainties within cumulative and trend in the Czech Republic and Slovakia aggregate exposure assessment in toddlers as a sensitive and vulnerable group. Other advancing BUŠOVÁ Milena aspects would be based on a regular post-marketing Charles University, First Faculty of Medicine, Institute monitoring of the non-professional use of biocides, and on of Hygiene and Epidemiology, Prague the epidemiology of children admitted to antipoisoning centres for suspect intoxication. The systematic presence Jana Babjaková – Comenius University in Bratislava, Faculty of Medicine, Institute of Hygiene of fipronil products indoors would represent evidence by which to direct and prioritise environmental and food risks Acrylamide (AA) is a contaminant formed in including the persistence of fipronil products in remediated carbohydrate-rich foods during ordinary heat waters and biosolids from civil wastewater treatment plants, treatment of food at temperatures above 120°C, and that proposed for agriculture use and for the pest such as baking, frying, roasting, etc. This is classified resistance outcomes. as a process contaminant with negative effects on human health. Acrylamide negatively affects the nervous system, reproduction, prenatal and post- 6. Risk assessment of arsenic (As) in rice natal development. IARC has included acrylamide as and rice-based products consumed a substance that is probably carcinogenic to humans by toddlers in Switzerland (group 2A). Food safety authorities have recommended the long-term monitoring of acrylamide levels in food.

BRÜSCHWEILER Beat The aim of our study was to determine the Federal Food Safety and Veterinary Office (FSVO) acrylamide content in samples of commonly available foods from market chains in the Czech Roxane Guillod-Magnin, Rafael Aubert, Max Haldimann – FSVO Republic (CR) and compare these with data on long-term occurrence of acrylamide in food in the Because rice has the ability to accumulate arsenic, CR and the Slovakia (SR). In total, 42 food samples the levels of inorganic arsenic (iAs) in rice are were analysed: potato chips, biscuits, popcorn, generally 10-fold higher than in other cereals. cornflakes, extruded breakfast cereals for children Therefore, rice and rice-based products contribute and baked muesli. The analysis was carried out in

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an accredited laboratory using high pressure liquid outbreaks have been reported in Spain and Portugal, chromatography (HPLC). The results confirmed that specifically in Macaronesia. The EuroCigua project the lowest content of acrylamide was in extruded focuses on characterising the risk of ciguatera breakfast cereals (mean 89 μg kg–1). The low AA food poisoning in Europe. The main objectives content was determined in roasted muesli (mean are: to determine the incidence of ciguatera in 126 μg kg–1) and cornflakes (mean 115 μg kg–1). The Europe; to assess the presence of ciguatoxin in highest AA values were determined in potato chips food; and to develop and validate methods for (mean 982 μg kg–1) and popcorn (mean 761 μg kg–1). the determination of ciguatoxin contaminated Eleven products (potato chips, popcorn and corn specimens. In this manuscript, an update of results biscuits) exceeded the recommended guideline is presented. First an epidemiological surveillance values for acrylamide given by the Commission protocol for ciguatera in the EU has been developed. Recommendation (2013/647/EU) 8 November 2013. This protocol includes a consensus definition for For samples of corn products, it can be seen that the ciguatera food poisoning, the recommended public used technology can affect the total AA content in health measures and two specific questionnaires for the final product. According to the results of long- ciguatera cases and outbreaks. Secondly, potentially term monitoring of acrylamide levels in common ciguatoxin (CTX) producing species of the genera foods in the SR from a total of 544 specimens in Gambierdiscus and Fukuyoa have been identified the period 2006–2014, the highest average amount in Macaronesia (Canary Islands and Madeira) and of AA was found in coffee (707.8 μg kg–1), potato in the Mediterranean area. Gambierdiscus has products (409.8 μg kg–1), durable pastry (318.6 μg been described for the first time in the western kg–1) and other cereal products (302.6 μg kg –1). Mediterranean in the Balearic Islands. Taxonomic evaluation, implementing morphological evaluation Our study showed results that were consistent with and molecular genetics have been carried out. long-term monitoring of food in the Czech Republic Cultures of these species have been established and, and the Slovak Republic. The highest concentration in some strains, production of CTX-like compounds of acrylamide was found in foods made from has been identified. Finally, EuroCigua is also potatoes and corn flour. Since 11 April, Commission focused on the development and optimisation of Regulation (EU) 2017/2158 20 November 2017 has an LC-MS/MS method for the confirmation of the entered into force establishing mitigation measures CTX toxicity in fish samples from the Canary Islands and reference values for reducing the presence of and Madeira, previously identified as positive by acrylamide in foods. neuroblastoma cell assay (N2a). The purification steps of sample preparation and the optimised conditions for an increased sensitivity of the mass 8. Risk characterisation of ciguatera spectrometry analyser have been evaluated, food poisoning in Europe. GP/EFSA/ allowing the detection of CFP toxins at ppb levels. AFSCO/2015/03 (EUROCIGUA): At this stage of the project, the studies show that preliminary results Caribbean ciguatoxin, and in particular C-CTX1, is the main responsible agent for the contamination of fish from the Canary Islands and Madeira. CANALS Ana Spanish Agency for Consumer Affairs, Food Safety and Nutrition 9. Risk assessment of nitrates as food Ana Canals, Laura Cebadera-Miranda, Cristina Alonso additives: an integrated approach Andicoberry – AECOSAN Carmen Varela, Elena-Vanesa Martínez – Institute of Health Carlos III CHRISTODOULIDOU Anna EFSA Domingo Núñez, Francisco Martín – Canary Health Service Miriam Friedemann – BfR Fernando Aguilar, Riccardo Crebelli, Alessandro Di Mónica Oleastro – Instituto de Saúde Doutor Ricardo Jorge, IP Domenico, Maria Jose Frutos, Ursula Gundert-Remy, Jean-Charles Leblanc, Piet van den Brandt, Cristina Fortes, Ioannis Boziaris – University of Thessaly; Leonardo Merino – EFSA WG on Nitrates Fernando Real – University of Las Palmas de Gran Canaria Davide Arcella, Anna Christodoulidou, José Cortiñas Pedro Reis-Costa – IPMA Abrahantes, Federica Barrucci, Anna Garcia, Fabiola Pizzo, Neide Gouveia – Fisheries Department. Direção Regional Dario Battacchi – EFSA staff das Pescas of Madeira Maged Younes – EFSA WG on Nitrates G Papageorgiou – General State Laboratory, Ministry of Health of Cyprus The Panel on Food Additives and Nutrient Sources Aligisaki Aikaterini – University of Thessaloniki added to Food (ANS) provided a scientific opinion Jorge Diogène – IRTA re-evaluating the safety of sodium nitrate (E 251) and potassium nitrate (E 252) when used as food PA Estevez, D Castro, JM Leao, Ana Gago Martínez – University of Vigo additives. The current acceptable daily intakes (ADIs) for nitrate of 3.7 mg/kg body weight (bw) Ciguatera food poisoning is one of the most per day were established by the SCF (1997) and common foodborne illnesses related to seafood JECFA (2002). The available data did not indicate consumption world-wide, mainly in tropical genotoxic potential for sodium and potassium and subtropical areas. However autochthonous nitrate. The carcinogenicity studies in mice and rats

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were negative. The Panel considered the derivation regulatory reference values, main targets/end points of an ADI for nitrate based on the formation of and the impact of the studies conducted in mouse methaemoglobin, following the conversion of on these parameters were extrapolated. nitrate, excreted in the saliva, to nitrite. However, The analysis is expected to contribute to a weighted there were large variations in the data on the assessment of the utility of including the mouse nitrate-to-nitrite conversion in the saliva in humans. as a second rodent species in pesticide risk Therefore, the Panel considered that it was not assessment, also in the light of the principles of the possible to derive a single value of the ADI from 3Rs (Replacement, Reduction and Refinement) the available data. The Panel noticed that even in animal research. Moreover, such analysis will using the highest nitrate-to-nitrite conversion mainly focus on the evaluation of the mouse and its factor the methaemoglobin levels produced due contribution to carcinogenesis risk assessment. to nitrite obtained from this conversion would not be clinically significant and would result to a theoretically estimated endogenous N-nitroso compounds (ENOC) production at levels which 11. EFSA scientific protocol for the re- would be of low concern. Hence, and despite the assessment of the safety for consumers uncertainty associated with the ADI established by of bisphenol A (BPA) the SCF, the Panel concluded that currently there was insufficient evidence to withdraw this ADI. The CROERA Cristina exposure to nitrate solely from its use as a food FIP Unit, EFSA additive was estimated to be less than 5% of the overall exposure to nitrate in food based on a refined Anna Federica Castoldi, Claudio Putzu – FIP Unit, EFSA estimated exposure scenario. This exposure did not Fulvio Barizzone – AMU Unit, EFSA exceed the current ADI (SCF, 1997). However, if all Julia Cara Carmona – FIP Unit, EFSA sources of exposure to dietary nitrate are considered (food additive, natural presence and contamination), Ursula Gundert-Remy – Charité Medical School Berlin, Institute for Clinical Pharmacology and Toxicology the ADI would be exceeded for all age groups at the mean and the highest exposure. To ensure an efficient, transparent and rigorous re- assessment of the safety for consumers of bisphenol A (BPA), the European Food Safety Authority 10. The relevance of mouse as second (EFSA) has developed a protocol detailing a priori animal species for the identification of the approach and methodology to be used. The carcinogenesis hazard protocol defines upfront methods and criteria for data collection, study inclusion, evidence appraisal (internal and external validity) and evidence CIVITELLA Consuelo integration (e.g. weight of evidence, confidence in EFSA the body of evidence). Pre-defined inclusion criteria (e.g. publication date after December 2012 or data Andrea Terron – EFSA submission via a call for data, any exposure route, Animal testing is still part of the current standard to any toxicological end-point, etc.) are considered. A explore the potential carcinogenic effect of chemical systematic review approach is applied to human substances. In particular, the 2-year studies performed and animal evidence, potentially suitable for deriving in laboratory rodents have been for years the primary a reference dose for setting a tolerable daily intake method by which chemicals are identified as having (TDI), whereas other types of evidence, e.g. cross- the potential to be hazardous to humans. sectional and toxicokinetic studies, are dealt with narratively. An appraisal tool adapted from the 2015 For plant protection products (PPPs), Regulation (EU) NTP-OHAT is employed to rate the internal validity of 283/2013, setting out the data requirements for active human or animal studies, according to design and substances, indicates that long-term carcinogenicity end-point. The external validity is assessed only on studies should be conducted in two rodent species, the animal studies by criteria taken from the 2014 with a default preference for rat and mouse. Science in Risk Assessment and Policy (SciRAP). Several reviews published in the last 3 decades from The experts next assign confidence ratings (High, the pharmaceutical, industrial and agro-chemical Moderate, Low or Very Low/missing data) to the sectors (von Wittenau and Estes, 1983; Alden et al., body of evidence for each end-point and translate 1996; Doe et al., 2006; EFSA 2007; Billington et al., 2010; them into levels of evidence for a certain health or Boobis 2016) highlighted the low impact of having no health effect. The final integration of the levels information from a mouse carcinogenicity study in of evidence from the human and animal streams the assessment of human safety and classification. into the likelihood of a health or no health effect identifies the effects/studies on BPA suitable for However, conducting a mouse carcinogenicity study the hazard characterisation. We believe the correct currently remains a global requirement for the implementation of such a structured protocol will successful registration of agrochemicals. result into a methodologically rigorous re-evaluation The present study reviewed pesticide evaluations of the temporary TDI for BPA of 4 µg/kg bw per day to determine studies and endpoints used to derive set by EFSA in 2015 and will in turn enhance the guidance values and safety factors applied. From public trust in EFSA’s risk assessment work. this evaluation, the frequency of species used to set

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12. Acute exposure of the Italian young 13. Risk assessment of nanomaterials population to tropane alkaloids through used in food-related applications: in vitro cereal-based food consumption: tests to assess dissolution and biological a preliminary estimate at a local level fate

DI NARDO Serena FERRARIS Francesca Istituto Zooprofilattico Sperimentale della Lombardia Istituto Superiore di Sanità e dell’Emilia-Romagna (IZSLER) Sara Savini, Andrea Raggi, Federica Aureli, Francesco Elisabetta Caprai, Stefania Bonan, Giorgio Galletti, Tamba Cubadda – Istituto Superiore di Sanità, National Institute Marco, Giorgio Fedrizzi – IZSLER of Health, Rome, Italy

Tropane alkaloids (TAs) are secondary metabolites In the food sector, applications of nanotechnologies of several plants, characterised by an acute toxicity to agricultural production, food processing and on the nervous system. EFSA established a group food-contact materials are rapidly developing. ARfD of 0.016 μg/kg bw expressed as the sum of Nanotechnology applications in the food sector may (−)-hyoscyamine and (−)-scopolamine, assuming bring benefits; conversely, potential risks have to be equivalent potency. assessed and excluded since, if nanoparticles persist as such after gastrointestinal digestion, they may be The present study was carried out on 82 cereal- absorbed in the gut. based food samples collected in Lombardia and Emilia-Romagna regions during 2016–2017 and Nanomaterials that quickly and completely dissolve/ analysed for TAs by the Food Chemical Department degrade in the gastrointestinal tract do not give of the IZSLER using a validated LC-MS/MS method. rise to nanospecific concerns as in the absence LOQ value was 0.3 µg/kg for cereals. of exposure no risk is expected. In the NANO- PERSIST project, carried out within the Open Most sample concentrations (97.6%) were below Access initiative in collaboration with the EC-JRC, the LOQ. Four samples showed the presence of the transformations and potential dissolution of atropine or scopolamine, namely: a rice-based nanoparticles under conditions representative of cream and a maize-based cream intended for infant the gastrointestinal tract will be studied by means consumption, and two buckwheat products. of an in vitro method simulating human digestion A preliminary investigation was performed on that mimics physiological conditions in vivo, taking the acute exposure to the sum of atropine and into account the presence of digestive enzymes and scopolamine by infants, young children and their concentrations, pH, digestion time and salt teenagers consuming cereal products. Two scenarios concentrations. were assessed. If there is potential for systemic exposure, i.e. if First scenario considered real data for mean and nanoparticles persist as such after gastrointestinal high consumers. Infant exposure ranged from digestion and are absorbed, their biopersistence 0.0008 to 0.0104 µg/kg b.w./day; children exposure in the human body is an essential driver of their ranged from 0.0012 to 0.0045 µg/kg bw/day; toxicokinetics behaviour and potential toxicity. An teenagers exposure ranged from 0.0011 to 0.0031 µg/ in vitro test in artificial lysosomal fluid will be used kg bw/day. to have an insight into the bio persistence and the biological fate of nanoparticles in the human body. A worst-case scenario was calculated taking into account left-censored data in an UB approach, The above-mentioned acellular in vitro tests are assuming a concentration of 0.29 µg/kg for samples key to assess the dissolution/bio persistence of below the LOQ. Infants exposure ranged from 0.0011 nanomaterials used in the food and nutrition sector to 0.0431 µg/kg b.w./day; children exposure ranged and form the basis of the risk assessment strategy from 0.0006 to 0.0089 µg/kg b.w./day; teenagers for these materials. Validation and standardisation exposure ranged from 0.0004 to 0.0066 µg/kg b.w./day. of these methods for the assessment of nanotechnology products is therefore an urgent The preliminary study shows that the group ARfD research need. In the NANO-PERSIST project is not exceeded within the first scenario. If left- they will be applied for the first time to a range of censored data are assessed, the acute exposure of nanomaterials of relevance for the agri-food sector infants to the sum of TAs could exceed the ARfD. and fit for purpose, state-of-the-art analytical However, the worst-case assessment was very methods will be used for the physicochemical conservative and affected by severe uncertainties, characterisation of the particles. mostly related to a large number of left-censored data and the lack of updated consumption information.

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14. Assessment of food contamination and handling of contaminated foods. In Chile, and dietary intake of lead and thallium the National Programme of Surveillance (PNV) of in a Northern Italy population Mycotoxins in Food of the Ministry of Health has found both mycotoxins in dry chilli pepper often in high levels. The aim was to estimate OTA and FILIPPINI Tommaso AFs exposure by red chilli powder consumption University of Modena and Reggio Emilia (UNIMORE) in a Chilean rural area by the Probable Intake (PI) Marcella Malavolti, Silvia Cilloni, Federica Violi, Carlotta estimation, based on: (a) reported consumption of Malagoli – UNIMORE red chilli powder; and (b) OTA and AFs concentration in red dry chilli according to the PNV of Mycotoxins Luciano Vescovi – IREN Reggio Emilia of 2016. Normal distribution of data and probabilistic Marco Vinceti – UNIMORE models based on Monte Carlo simulation were Lead and thallium are heavy metals released in assumed. According to the food consumption the environment after natural and anthropogenic survey, 26% of the subjects are dry chilli consumers, activities. Food and water intake are the major with a mean of 1.93 ( ± 2.26) g/day, without significant sources of human exposure to these elements. In differences between gender and ages. The reported this study, we aimed at characterising lead and 2016 prevalences of OTA and AFs in red chilli powder thallium content in foods consumed in northern were 45% (13/29) and 21% (6/29), with average levels of Italy population, to estimate the dietary intake of 19.87 (± 20.36) and 1.8 (± 0.72) ng/kg respectively. The these metals. To undertake this that we bought food estimated mean IP was 1.185 (± 1.172) ng/kg weight/ samples in markets and groceries collected during day for OTA and 0.082 (± 0.065) ng/kg weight/day the period from October 2016 to February 2017 in for AFs. In a worst-case scenario, the IP would be the Emilia-Romagna region, and we measured 33.5 ng/kg weight/day for OTA and 1.5 ng/kg weight/ their element content using inductively coupled day for AFs. In Chilean rural areas, exposure to OTA plasma-mass spectrometry. Finally, after assessing due to red dry chilli consumption would be low in dietary habits of an Emilia-Romagna community average consumption but could reach dangerous by using a validated food frequency questionnaire, levels in the worst-case scenario. Both toxins are we eventually estimated dietary intake of these present in foods consumed in Chile, so it is urgent to metals in that community. In the 890 analysed food study other sources and measure biomarkers in the samples, the highest lead contamination levels population for a more accurate exposure assessment. were found in seafood, vegetables, sweets and beverages. The estimated dietary intake of lead was 5.758 (interquartile range (IQR): 4.547–7.427) µg/day, 16. Occurrence of different mycotoxins corresponding to 0.089 (IQR: 0.069–0.113) µg/kg of (including emerging mycotoxins body weight per day, with cereals, beverages and and ergot alkaloids) in feeds from Spain vegetables as major contributors. For thallium, one- third of specimens showed very low levels below the limit of detection, with the highest contamination GÁMIZ-GRACIA Laura levels in vegetables, dry fruits and sweets. The University of Granada dietary intake of thallium was 0.236 (IQR: 0.183–0.312) Natalia Arroyo-Manzanares – University of Murcia µg/day, mainly from vegetables, beverages, cereals Plácido Arenas-Fernández – University of Granada and sweets. In conclusion, our study provides an estimation of lead and thallium intake in a northern Ana M García-Campaña – University of Granada Italian community and shows a generally low Lourdes Arce-Jiménez – University of Cordoba exposure levels from dietary sources. Vicente Rodríguez-Estévez – University of Cordoba

Mycotoxins are toxic secondary metabolites produced by certain fungi. Among these, there are 15. Exposure estimation for ochratoxin A well known hazards such as aflatoxins (considered and aflatoxins due to red chilli powder as carcinogenic by the IARC) or ochratoxin A. consumption in a Chilean rural area Currently, several mycotoxins are considered in the EU legislation and maximum contents have been FOERSTER Claudia established in different food commodities. However, Universidad de O’Higgins there are still some mycotoxins with no limits established, but with some evidences of adverse Andrea Rivera – Chilean Health Ministry effects on human health. These are the so-called Sandra Cortés – Pontificia Universidad Católica de Chile/ emerging mycotoxins, including some Fusarium ACCDiS toxins such as enniantins and beauvericin. Catalina Pinto – Universidad de O’Higgins In a recent survey, 228 feed samples for pigs from Manuel Pinto – Universidad de O’Higgins different locations in Spain have been analysed in Catterina Ferreccio – Pontificia Universidad Católica our laboratory, trying to explore the occurrence de Chile/ACCDiS of mycotoxins (including aflatoxins B1, B2, G1 and G2, ochratoxin A, fumonisins B1 and B2, citrinin, Ochratoxin A (OTA) and aflatoxins (AFs) are zearalenone, deoxynivalenol, fusarenone X, carcinogenic toxins produced by fungi, whose sterismatocystin, T2-toxin, HT2-toxin, enniantins A, exposure is associated with the consumption A1, B and B2, beauvericin and 12 ergot alkaloids). The

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results showed that the 100% of the samples gave of some mycotoxins through their habitual diet and positive results for enniantin B (up to 1,200 µg/kg) that maximum permitted levels in food do not fully and more than 90% for beauvericin. Moreover, more protect them from exceeding TDI. than 40% samples were contaminated with more Reference than five different mycotoxins. In the EFSA Scientific [1] Gratz SW, Richardson A, Duncan G, Holtrop G (2014): Annual Opinion on the risks to human and animal health variation of dietary deoxynivalenol exposure during years of related to the presence of beauvericin and enniatins different Fusarium prevalence: a pilot biomonitoring study. in food and feed, it was concluded ‘the chronic Food Additiv Contamin A 31(9), 1579–1585. exposure for poultry indicated that adverse health effects from beauvericin and enniatins were unlikely. For other considered animals, the lack of LOAELs/ 18. Assessing the safety of ethnic foods NOAELs precluded the estimation of chronic health consumed in the United Kingdom risk from beauvericin and enniatins’. These results, show the necessity of establishing an estimation of HARIS Parvez this risk and, if necessary, the proposal of maximum De Montfort University limits also for these emerging mycotoxins. Moreover, the synergic effect of different mycotoxins should Shaban Al-Rmalli, Richard O. Jenkins – De Montfort also be explored. University, UK

We have been engaged in research monitoring the presence of toxic elements, including arsenic, in 17. Multimycotoxin exposure assessment different foods that are imported into the United in children using urinary biomarkers Kingdom (UK) that are consumed by different population groups. Exposure to toxic elements GRATZ Silvia W can lead to development of different diseases and Rowett Institute, University of Aberdeen therefore a knowledge of foods that are potentially harmful is needed. In this context, our research is V Currie, G Duncan, R Slater, D Jackson – Rowett Institute, directed at protecting public health and nutrition by University of Aberdeen, UK identifying foods that have high content of arsenic, Cereal foods are commonly contaminated with cadmium and lead and also looking for alternatives multiple mycotoxins resulting in frequent mycotoxin that have lower content of such elements. Foods exposure in humans. Tolerable daily intakes (TDI) sold in the UK market were purchased and and maximum permitted levels are set by food analysed using inductively coupled plasma-mass safety authorities world-wide to protect consumers spectrometry. Our analysis reveal that rice and from mycotoxin toxicity. Children have been certain types of vegetables have high content of described at high risk to be exposed to high levels toxic elements which may increase human exposure of mycotoxins due to their high intake of cereal to these elements in those populations that foods in relation to body weight. Here we use a consume large quantities of these foods on a regular multimycotoxin detection method in urine to assess basis. We have also identified certain types of rice, mycotoxin exposure in children. especially aromatic rice, that are very low in arsenic that could be consumed by people who eat large Spot urine samples were collected from 21 children quantities of rice on a regular basis. Findings of our (age 2–6 years) following their habitual diet. studies and the potential risk to human health will 4 ml of urine sample were spiked with internal be presented. standards (13C labelled DON, ZEN, HT2, OTA, AFB1), incubated with β-glucuronidase (37°C, 18 h) and passed through Myco6in1 immunoaffinity columns. Eluents were dried, reconstituted in 10% ethanol 19. The impact of synthetic amorphous and injected (10 µl) into a Shimadzu Nexera X2 LC silica (E 551) on advanced in vitro models coupled to a Shimadzu 8,060 triple-quadrupole of the human intestinal barrier MS. The mobile phase gradient changed linearly from 95% A (10 mM ammonium acetate) to 95%B HEMPT Claudia (methanol) over 10 min. Daily exposure to DON, ZEN EMPA – Swiss Federal Laboratories for Materials Science and OTA was estimated from urinary mycotoxin and Technology concentrations using urinary creatinine excretion, renal clearance rate and mycotoxin excretion rate [1] Jean-Pierre Kaiser, Alexandra Rippl, Melanie Kucki, Peter and expressed as% of TDI. Wick, Tina Buerki-Thurnherr, Cordula Hirsch – EMPA, Swiss Federal Laboratories for Materials Science and Technology, Urinary levels were high for DON (14.65 ± 12.69 ng/ Lerchenfeldstrasse 5, 9014 St. Gallen, Switzerland ml) but low for NIV (0.34 ± 0.21), OTA (0.05 ± 0.02) and ZEN (0.08 ± 0.06). Some of the urine samples In recent years food industry faced different aspects contained DOM-1 (2/21), T2 (1/21), HT2 (1/21), αZEL (3/21) of nanotechnology. Engineered nanomaterials and βZEL (2/21) and none of the samples contained (ENM) may have been developed to provide for AFB1, AFM1 or OTα. Children were exposed to levels example new tastes, antimicrobial properties or to above the TDI in 58% of cases (DON), 8% of cases improve the nutritional value of food (novel food). (OTA) and none of the cases for ZEN. Our data clearly Alternatively, nanostructured synthetic amorphous demonstrate that children are exposed to high levels silica has been mainly used as anticaking agent for

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decades. It does not generate novel food characteristics was proposed [1]. This method was applied for but rather serves as a technological additive. developing a survey of the levels of these 12 dyes (Amaranth, Ponceau 4R, Carmine, Ponceau SX, The impact of nanomaterials on the gut epithelium Ponceau 3R, Allura Red AC, Carmoisine, Erythrosine, and their translocation through the intestinal barrier Sudan I, Sudan II, Sudan III and Sudan IV) both in is poorly investigated and understood. Therefore, fresh meat preparations and in meat products. we aim to mechanistically study the interaction of nanostructured silica with the mucosal lining and In total, 130 samples (65 meat products and 65 distinct cell types of the intestinal barrier. A panel fresh meat preparations) were analysed. Carmine of 10 different synthetic amorphous silica products, and Ponceau 4R were the only dyes quantified in suitable as E 551, which differ in size, surface area meat products. Except for one sample of salami, and production route will be assessed to identify they were regularly indicated on the label, and their potential structure-activity relationships. concentrations were lower than legal limits (in the range 1.3–8.1 and 6.2–86.4 mg kg–1 for Ponceau 4R To elucidate the impact of synthetic amorphous and Carmine, respectively). Regarding fresh meat silica on enterocytes, the most prevalent cell type preparations, Carmine was detected in two samples, of the intestinal barrier, 21-day fully differentiated confirming that this dye is still used, although it is no Caco-2 monocultures were employed. The Caco- longer authorised. 2 monocultures displayed cell type-specific morphology, formed intact barriers and expressed Reference cell type-specific antigens. All investigated [1] Iammarino M. et al. 2017. Abstract Book 8th RAFA. 279. nanostructured silica products did not affect barrier Funding integrity, cell viability or the formation of reactive Work was supported by the Italian Ministry of Health. Project oxygen species up to a concentration of 50 μg/ml in GR-2013–02358862. differentiated Caco-2 cells. The next steps will be the establishment of co- and triple cultures of enterocytes (Caco-2), goblet 21. Possible health risks of cells (HT-29-MTX) and B-lymphocytes (Raji) and nanotechnology in the food industry subsequent studies on the impact and translocation of synthetic amorphous silica, suitable as E 551, in ILYASOGLU BUYUKKESTELLI Hulya these more physiological models. Ege University

B Hızlar, SN El, S Karakaya – Ege University, Engineering 20. Monitoring on the presence of 12 Faculty, Food Engineering Department, 35100 Izmir, Turkey dyes in fresh meat preparations and Nanotechnology is a field of applied sciences and meat products as a contribution to risk technologies focusing on the characterisation, assessment fabrication and manipulation of biological and non-biological structures below 100 IAMMARINO Marco nanometres. Nanotechnology offers a wide range Istituto Zooprofilattico Sperimentale della Puglia of opportunities in food sector involving food e della Basilicata manufacturing, processing and food packaging. While this technology brings many advantages Annalisa Mentana, Diego Centonze, Carmen Palermo such as improved bioavailability, sensorial attributes – Department of the Sciences of Agriculture, Food and and solubility, the safety risks associated with Environment, University of Foggia, Via Napoli, 25, 71122 nanomaterials should be considered. Nanomaterials Foggia, Italy; exhibit different properties compared to their micro Michele Mangiacotti, Antonio Eugenio Chiaravalle – form and this can lead changes in the absorption Istituto Zooprofilattico Sperimentale della Puglia e della profile and metabolism in the body. They have Basilicata, Via Manfredonia 20, 71121 Foggia, Italy. potential to carry undesirable molecules across The External Scientific Report of the European gastrointestinal tract. Another issue that should be Commission entitled: ‘Analysis of needs in post-market handled is the potential toxicity of particles when monitoring of food additives and preparatory work transformed into nanoscale. Once they ingested, it for future projects in this field’, concludes that ‘The is possible to migrate and accumulate in different groups of sweeteners and food colours were identified tissues and organs such as brain, kidney and liver. as priority substances to be addressed in post-market In vitro studies have shown that nanomaterials can monitoring’. In effect, data related to the food dyes interact with normal cellular barriers by crossing quantification in foodstuffs are lacking. Regarding cellular barriers and cause oxidative damage. This meat products, this gap is also due to the attention of review provides an overview of the potential health official controls, usually focused on other food additives risks such as heavy metal release, allergen carbon (i.e. nitrites/nitrate and sulphites, etc.). However, the nanomaterials and silicium oxide nanoparticles use/abuse of food dyes in meats has to be constantly in nanotechnology applications. Suggestions and monitored, due to several food safety concerns. corrective actions (e.g. categorising nanomaterials for risk assessment and multicriteria decision Recently, a fully validated method for the determination analysis) will be given to researchers and producers of 12 food dyes in meat products, based on in food industry with a future outlook. HPLC coupled with UV-Diode Array Detection,

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22. Transfer of deoxynivalenol in herbal Furthermore, the sensitivity of the consumer’s allergic tea infusions reaction might be influenced by the processing and refining process of food ingredients. JAUKOVIĆ Marko Soybean allergy is one of the most common food Jugoinspekt Beograd allergies, especially in babies and children. Allergic reactions to soy are typically mild, but all reactions Deoxynivalenol (DON) is a mycotoxin belonging to can be unpredictable. There are number of potential the group of trichothecenes, produced by various soybean allergens such as glycinin 11S globulin Fusarium species. It contaminates mainly grains fraction and beta-conglycinin subunit. Most of their and cereal-based food and feed, however it could allergenic activity could be described by IgE binding. be found in herbs as well. The aim of this study The quantitative analysis of soy residue of 20 was to assess DON transfer into tea infusions. This soybean-derived cosmetic ingredients is performed type of preparation (putting a tea bag into boiling using Veratox for Soy allergen No. 841. Although water) is very common world-wide. An infusion many of the issues surrounding variability in usually brings the soluble ingredients into solution. analytical techniques can be addressed, controlling Therefore, DON with its good solubility in water the limit of soy protein content might be the first could be a potential risk for human health. This step of securing the safety of raw materials. study focuses on peppermint tea because it is most commonly consumed in Serbia. To determine the Although there is an argument about the transfer rate, 10 samples of naturally contaminated connection between food allergies and contact peppermint teas were used to prepare infusions. dermatitis, plants known to have type I allergen Quantification of DON in infusions was determined are required more safety studies related to skin by HPLC-UV with DONStar R immunoaffinity clean- sensitisation. up columns. Concentration of DON in prepared tea infusions was no significantly different from naturally contaminated raw samples which means 24. Acute toxicity assessment of combined that transfer of DON was complete (100%). These pesticide formulation taking into account data are important for the realisation of a ‘Total Diet adjuvants and in silico modelling to address Study’ (TDS). The TDS can be a complementary further risk assessment of mixtures. tool to estimate the population dietary exposure to DON across the entire diet by analysing main foods prepared ‘as consumed’, however in this case could KOLESNYK Serhii be analysed ‘as purchased’ (raw tea). A provisional L.I. Medved’s Research Centre of Preventive Toxicology, tolerable daily intake (TDI) for DON was set in 2002 Food and Chemical Safety, Ministry of Health by the Scientific Committee for Food (SCF) at 1 μg/kg Mykola Prodanchuk, Petro Zhminko, Elena Riabuha, body weight (bw) per day. At the moment maximum Olesia Vasetska, Nataliia Bubalo, Yana Kolianchuk – L.I. limit (ML) for deoxynivalenol in tea is not set. Medved’s Research Centre of Preventive Toxicology, Food and Chemical Safety, Ministry of Health Ukraine

Results presented are development of research 23. Safe use of plant derived ingredients idea reported on EFSA Risk Assessment Research known to have type I allergen in cosmetics Assembly in February 2018 in Utrecht. Mixture toxicity is on growing interest of society, KIM Seoyoung regulatory authorities and researchers. Number of Amorepacific R&D Centre studies show possibilities of adverse effect of mixtures where substances presented in doses not causing The safety of cosmetics used daily by consumers effect individually. Given whole mixture approach is is critical and assurance of product safety is one not feasible as regular practice for risk assessment of of the most important factors considered by the mixtures, there is need to develop integrated testing cosmetics company. As consumer issues grow strategy using alternative methods. In this work, related to food (such as hydrolysed wheat protein, we present acute in vivo testing and first steps in peanut, and soybean) and skin allergies, managing selection of in silico methods. standards for food allergy-related components of cosmetic ingredients are needed. Recently, the We conducted studies of acute toxicity (Wistar Han European Commission issued a new Regulation rats, OECD 425) of eight pesticide formulations, (EU) 2017/2228, regarding the safe use of peanut contained 2 or 3 pesticides (azoxystrobin, oil, its extracts, its derivatives and hydrolysed wheat cyproconazole, difenoconazole, flutriafol, proteins in cosmetics, to amend Annex III of (EC) No. imidacloprid, lambda-cyhalothrin, propiconazole, 1223/2009. spiroxamine, tebuconazole, thiabendazole, thiram, triadimefon, triadimenol). Results showed that It is still controversial whether or not a consumer coefficient of additivity calculated on the basis having a food allergy can cause contact dermatitis or of active ingredients (AI) LD50 characterise allergic dermatitis when they use cosmetic products potentiation of toxicity (4 formulations); in two containing food allergens. The susceptibility of skin formulation we have observed antagonistic sensitisation might be different depending on interaction; one formulation caused dose addition individual susceptibility and potency of food allergens.

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effect for males and synergistic effect for females. 26. Risk thermometer-based ranking of Results of calculation of additivity coefficient chemical food contaminants and additives taking into account other than AI components of formulation will also be presented. LANGERHOLC Tomaz Data on repeated dose, reproductive and other University of Maribor, Slovenia long-term effects of pesticide active ingredients is available. So, we decided to discover if in silico tools Salomon Sand – Swedish National Food Agency, Uppsala, may be used to decide if further toxicity studies Sweden and mixture risk assessment for tested in acute Food regulatory agencies have to plan their experiment active ingredients and adjuvants is workload and directions of work. For this purpose, needed. We conducted in silico toxicity modelling risk ranking of chemicals in foods is an important of AI and adjuvants using different publicly available tool to set priorities and to enable a more risk-based QSAR and molecular docking models (with accent transparent decision on prioritisation of health issues. on endocrine disruption mode of action and developmental and reproductive toxicity), compared Risk Thermometer is a novel food chemical ranking with available experimental data and presenting results. tool, that has been recently developed at the Swedish National Food Agency (NFA). Ranking of chemicals by this tool is based on consumer exposure data and health-based guidance vales 25. Trace heavy metals in dietary (HBGVs), but it also takes into account severity of supplements – analysis of market products the critical adverse health effects. For this purpose, EFSA risk assessment reports on chemical food KOZNIEWSKI Bartlomiej contaminants were used to extract required data JARS sp. z o. o. on consumption, HBGVs and tolerable daily intake (TDI)/Allowed Daily Intake (ADI) values when The growing trend in consumption of dietary applicable. In addition to contaminants, data on supplements must be followed by specific allowed representative food additives from diverse risk assessment connected with them. Those groups (colours, emulsifiers, sweeteners) have been products, comprising of heavily concentrated included in the ranking along with contaminants. nutritional components, vitamins and minerals, The risk ranking results have provided a new insight carry with themselves a number of risks, typically into the risks posed to consumers by contaminants not found in normal foods. One of these is heavy as well as additives in use by the food industry. The metal contamination and, in turn, the risk of ranking can be used as a basis for future mitigation heavy metal poisoning in consumers who often activities by authorities and communication treat a supplement as a replacement for a meal. between professional sectors and stakeholders Specific supplements carry with them a hazard involved, bridging the three aspects of risk analysis connected with specific heavy metals – animal (risk assessment, risk management and risk oil-based products often contain elevated levels of communication). mercury, calcium and magnesium preparations may contain traces of barium. Despite more and more harsh regulations being imposed on this class of ‘borderline’ products and the knowledge of 27. From cats to cattle: physiologically risks associated with ingestion of heavy metals, the based models for risk assessment in farm analysis of market-available preparations shows, and companion animals that producers often walk on the border between acceptable and hazardous products. LAUTZ Leonie The analysis concerns a number of (anonymously Radboud University presented) dietary supplements available in Poland Jean-Lou Dorne – European Food Safety Authority that underwent trace metal analyses in JARS Ad Ragas – Radboud University Laboratories and, using the suggested producer intake limits, assessed the risk of heavy metal The assessment of animal health risks due to accumulation and poisoning in occasional and chemical exposure has been highlighted as an area regular users of such preparations. which requires further development. We developed The topic presented here seems all the more generic physiologically based toxicokinetics models important as the lifestyle of European and global for five domestic animals, i.e. chicken, cattle, cat, consumers is changing and is faster and faster, swine and sheep, based on a systematic literature which forces many of them to treat dietary search of data on physiological parameters. The supplements as a panacea for tiredness, bad health models were applied to four compounds, i.e. and mood swings. Such users stand at a higher risk melamine, monensin, fipronil, oxytetracycline, of potential health hazards connected with regular covering a broad range of chemical classes. The uptake of even the smallest amounts of heavy models were tested in a data-rich environment, metals with food and supplements. with necessary model input parameters available, as well as in a data poor environment, where input parameters were extrapolated from other species. Overall, the models performed within a

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factor 10 when compared with measured blood 29. Contribution of dermal and oral uptake concentrations and tissue residues. The developed to internal bisphenol A exposure using models are useful for potential application in risk physiologically based pharmacokinetic assessment of animals, as they can be calibrated to fit the particularities of a variety of compounds and modelling species. Furthermore, the calculated concentrations in animal residues (i.e. meat, fat, milk, eggs) can be LINKE Susanne used to estimate the risk for human health. German Federal Institute for Risk Assessment

Ralph Pirow, Andreas Luch – German Federal Institute for Risk Assessment (BfR) 28. Integrating alternative methods to establish a residue definition Physiologically based pharmacokinetic (PBPK) modelling plays an increasing role in for dietary risk assessment the pharmaceutical area as well as in the risk assessment of industrial chemicals [1]. Flexible and LEUSCHNER Renata advanced software solutions for PBPK modelling EFSA are able to support the risk assessment of industrial chemicals. The dermal and oral uptake, and A Friel, J Parra Morte, R Serafimova, A Terron – Pesticide Unit, European Food Safety Authority (EFSA), Parma, Italy the toxicokinetics of bisphenol A (BPA) are not completely understood and existing uncertainties Pesticides are metabolised and transformed can be reduced by applying PBPK modelling. following their application on crops. This may lead The aim of the present study is to determine the to pesticide residues which can be composed of the contribution of dermal and oral uptake to internal parent compound and/or of a variety of metabolites. exposure of unconjugated BPA. The internal It needs to be assessed whether these residues are exposure after dermal uptake is different from that safe for the consumer. after oral absorption. This is due to very efficient A recent guidance of the EFSA Panel on Pesticide metabolism in the gut wall and the first pass effect Residues [1] aims to transparently define the of the liver. compounds to be included in the residue The software Simcyp simulator was used to set up definition for dietary risk assessment based on their PBPK models for humans for the oral and dermal toxicological significance and the amounts likely to routes. It provides the parametrisation for the be present. physiological parameters for different ages, sex and The innovative aspect of the EFSA guidance is a body weights (e.g. blood flows, organ volumes). multidisciplinary approach combining dietary Substance-specific parameters (e.g. pKa, logP, exposure assessment, pesticide residue science, partition coefficients) were taken from the literature toxicology and computational science. The or predicted based on quantitative structure- assessment is following a structured decision tree activity relationships (QSAR). Several studies on in approach composed of three modules. vitro clearance were taken into account. Finally, in vitro data on substance metabolism from the Genotoxicity and general toxicity assessment of literature was scaled to intrinsic organ clearance. metabolites, carried out in the first two modules, The contribution of dermal and oral exposure was employs computational toxicology and non- assessed. animal testing methods such as (Q)SAR modelling, grouping, read across in combination with available PBPK modelling is an appropriate way to predict the data and scientific information. internal exposure to consumer-relevant chemicals such as BPA. It is a powerful tool to simulate various In addition, the toxicological threshold of concern exposure scenarios (e.g. different dosing regimens, (TTC) can be applied to exclude metabolites exposure routes). The influence of the variability from further assessments based on a cumulative within a population and uncertainties of input exposure assessment. parameters can be addressed. In the third module a decision on the residue Reference definition for dietary risk assessment is derived, [1] World Health Organisation: Characterisation and application considering the contribution of relevant metabolites of physiologically based pharmacokinetic models in risk to the toxicological burden. assessment, WHO Library, 2010. The guidance can benefit from the EFSA’s pesticide genotoxicity database and the OECD MetaPath Project. The positions and opinions presented in this poster are those of the authors and are not intended to represent the views or scientific works of EFSA.

Reference [1] EFSA PPR Panel (EFSA Panel on Plant Protection Products and their Residues), 2016. Guidance on the establishment of the residue definition for dietary risk assessment. EFSA Journal 2016;14(12):4549, 129 pp.

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30. Non-linear associations between 31. Acrylamide: the carcinogen in your food dietary exposures to perfluorooctanoic acid or perfluorooctane sulfonate and MANZI Chiara type 2 diabetes risk in women: findings Associazione per la Sicurezza Nutrizionale in Cucina from the E3N cohort Antonella Cavazza – Università di Parma, Rinaldi, Massimiliano, Università di Parma MANCINI Francesca Romana Inserm Potatoes, cereals, bread: correlation between acrylamide content and colour changes. Francesca Romana Mancini, Kalina Rajaobelina, Delphine Praud, Courtney Dow, Jean-Philippe Antignac, Marina Chiara Manzi, the president of Art joins the Nutrition Kvaskoff, Gianluca Severi, Fabrice Bonnet, Marie-Christine Academy, EUROPEAN ANTIAGING CULINARY Boutron-Ruault, Guy Fagherazzi NUTRITION ACADEMY, together with ASSIC (The Italian Association for Nutritional Safety) and Background: The incidence of type 2 diabetes (T2D) reviewed the available scientific literature and data is rising world-wide: there is increasing interest to analyse the best cooking and processing methods in understanding the role played by endocrine- to reduce the exposure to acrylamide in foods. disrupting chemicals (EDCs). Perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) As potatoes are one of the food that contribute most are stable and persistent synthetic compounds, to overall dietary human exposure of acrylamide, suspected to act as EDCs and for which the diet is Chiara Manzi, together with Parma University and the main route of exposure. Art joins the Nutrition Academy, investigated the correlation between acrylamide content and colour Objective: To investigate the associations between of cooked potatoes. dietary exposure to PFOS and PFOA and the risk of T2D in the large E3N cohort study. The purpose of the present study was: Materials: This study included 71,294 women, free To develop a photographic tool to help consumers from T2D at baseline, who had answered semi- recognise acrylamide in foods. Results showed that quantitative food questionnaire containing 208 food the darker the colour of the potatoes, the more items. Overall, 2,680 women developed T2D during acrylamide is present. follow-up (1993–2012). To develop a method of cooking potatoes to be very low Methods: Dietary exposure to PFOA and PFOS was in acrylamide. potatoes were cooked in the oven (140– estimated for each study subject. Cox proportional 180°C) for 10 to 60 min (steam/hot air and no steam). hazards models, adjusted for the main know risk To develop a special cereal mix for cooking pizza factors of T2D, were used to estimate hazard ratios with very low levels of acrylamide. (HR) and 95% confidence intervals (CI). Women were classified into 10 groups using the deciles of the Acrylamide is a potentially cancer-causing distribution of PFOA and PFOS exposure, and the substance that naturally forms in starchy food lowest group was used as the reference category. products during high-temperature cooking, above about 120°C and low moisture. It is mainly formed Results: Mean dietary exposure to PFOS and PFOA from sugars and the amino acid asparagine that are was 0.50 ng/kg body weight/day and 0.86 ng/kg naturally present in many foods. body weight/day, respectively. PFOA and T2D had an inverse U-shape association: women in the fourth, In June 2015, EFSA confirmed that acrylamide in fifth, and sixth decile groups had a HR (95%CI) food potentially increases the risk of developing of 1.21 (1.06–1.46), 1.35 (1.15–1.59), and 1.33 (1.05–1.41), cancer and causes neuronal changes for consumers respectively, while the other decile groups were in all age groups. As acrylamide is present in a not associated to T2D. No association was found wide range of everyday foods, EFSA concluded that between PFOS and T2D, except when considering acrylamide is a public health concern that applies only women with body mass index (BMI) ≤ 25 kg/ to all consumers, but children are the most exposed m2, for which a positive non-linear association was age group on a body weight basis. observed. Certain foods are more likely to contain acrylamide Conclusion: Our findings highlight the importance than others. These include potato products of considering PFOS and PFOA low-dose exposure (especially french fries and potato chips), coffee, as a relevant risk factor for T2D. and foods made from grain (such as breakfast cereals, cookies, bread, crisp bread). Wholemeal products have been shown to contain more acrylamide. Acrylamide content can be related to colour: cooking starchy food to a golden yellow colour, rather than a dark brown colour, lowers the amount of acrylamide. Very brown areas contain more acrylamide. Since any level of exposure to a genotoxic substance could potentially damage DNA and lead to cancer, EFSA’s scientists conclude that they cannot set a

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tolerable daily intake (TDI) of acrylamide in food. data are critically important for proper interpretation Instead, EFSA’s experts estimated the dose range of the comet assay results. Two flavouring agents, within which acrylamide is not a concern for public perillaldehyde and 4,5-epoxydec-2(trans)-enal, health as 1 µg of acrylamide a day. This dose may be were recently tested in a rat comet assay and the found in 1 g of potato chips, 3 g of french fries, 4 g of highest administered dose was considered positive biscuits and 3 g of First Born biscuits. for DNA strand breaks. Subsequent pathology peer review identified evidence of hepatotoxic The conclusion of the present study was: effects challenging the appropriateness of that A photographic tool has been developed to help interpretation and clearly demonstrate the consumers recognise acrylamide in foods. Results importance of careful pathology evaluation of target showed that the darker the colour of the potatoes, tissues in the comet assay. Pathology peer review on the more acrylamide is present. comet assay tissues is strongly recommended. A method of cooking potatoes very low in acrylamide has been developed: potatoes were cooked in an oven (140–180°C) for 10 to 60 min 33. Testing new methodologies (steam/hot air). for identification of emerging chemical A special cereal mix for cooking pizza to be very low risks in food in acrylamide has been developed and produced. MERTEN Caroline Gabrielle Biography EFSA

Chiara Manzi graduated in Science in Human A Bitsch – Fraunhofer Institute for Toxicology and Nutrition and Dietetics (University of Navarra – Experimental Medicine (ITEM), Hannover, Germany Spain) and specialised in Antiaging Nutrition (Tufts M-L Bohlen – Forschungs – und Beratungsinstitut University of Boston). She is the founder of tCucina Gefahrstoffe mbH (FoBiG), Freiburg, Germany Evolution Academy, the first and only Academy of SE Escher – Fraunhofer Institute for Toxicology and Antiaging Culinary Nutrition in Europe. Partners Experimental Medicine (ITEM), Hannover, Germany of the Academy are the Universities of Parma and O Licht – Fraunhofer Institute for Toxicology and Milan. The Academy is sponsored by the Italian Experimental Medicine (ITEM), Hannover, Germany Ministry of Health. She is the president of the Italian M MacLeod – Stockholm University, Stockholm, Sweden Association for Nutritional Safety, one member J Oltmanns – Forschungs und Beratungsinstitut of its scientific committee is Massimo Bottura (3 Gefahrstoffe mbH (FoBiG), Freiburg, Germany Michelin stars and best Chef of the world 2016). She V Silano – EFSA expert is the teacher of Culinary and Antiaging Nutrition G Kass – EFSA, Parma, Italy at the University of Milan (Faculty of Medicine) and an expert for the class of Culinary Medicine at The objective of this study was to develop and test the University of Ferrara. She is involved in many a procedure for the identification of chemicals research projects together with the University of registered under the REACH Regulation that are Parma that have been published in international of potential health concern and are likely to occur scientific journals. She is the author of five books on in the food chain. For this purpose, 100 data-rich Culinary Nutrition. substances registered under REACH, together with four positive controls, were evaluated. The procedure consisted of a multistep selection 32. Importance of pathology peer review process following a sequence of selection criteria. in evaluating comet assays for genotoxicity The evaluation criteria of the 104 substances took into account parameters related to exposure (tonnage, release, biodegradation and potential MARONPOT Robert bioaccumulation) and toxicity (repeated dose Maronpot Consulting LLC toxicity, genotoxicity and reproductive toxicity) organised in six blocks. All substances were scored Shim-mo Hayashi – Scientific Director, Japan Flavour and Fragrance Materials Association for each block. ACC-HUMANsteady software was used to evaluate the potential for bioaccumulation Safety assessment of flavouring agents includes the in 11 different food items using input data derived successful completion of a battery of in vitro and in from QSAR predictions. Several weighting scenarios vivo genotoxicity assays. Regulatory authorities may were tested to aggregate scores for the six blocks request a mouse or rat comet assay for detection of into a total score to enable a ranking of the 104 DNA strand breaks in first contact tissues (stomach, substances. In addition, a Pivot table selection was duodenum) and the major site of metabolism (liver). implemented that can be used without weighting. Histopathology on these tissues is necessary to Further analyses compared the scores derived rule out test agent toxicity that could cause false- from experimental data with those derived from positive comet assay results. Since exposure to the predicted data. These analyses found a good test agent is only 3 days, very subtle tissue changes agreement of scores for biodegradability, but may be present that are easily missed during routine considerable disagreement of scores for toxicity histopathological examination. So, careful pathology endpoints. In conclusion, a scoring and ranking assessment of anatomical and clinical pathology procedure was developed for the identification of chemicals of potential concern in the food chain

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(potential emerging risks) that showed a good level Document for Developing and Assessing AOPs: 32. of differentiation. The focus on (semi-)automated *The positions and opinions presented in this poster are those processes ensures that this procedure can be of the authors and are not intended to represent the views or applied to all chemicals registered under the REACH scientific works of EFSA. Regulation.

35. High-resolution mass spectrometry 34. Adverse Outcome Pathway: redox-cycling as a tool for detection and identification of a chemical initiated by mitochondrial of organic substances of concern in food respiratory chain’s released electrons leading commodities as a part of the human to parkinsonian motor deficits exposome study

MINEO Desirée MIRALLES-MARCO Ana PRAS Unit, European Food Safety Authority (EFSA), Parma, RECETOX – Masaryk University Italy Alin Ionas, Veronika Schacht, Katerina Kademoglou, Hale Demirtepe, Garry Codling, Lisa Melymuk, Jana Klánová – A Terron – PRAS Unit, EFSA, Parma, Italy* Research Centre for Toxic Compounds in the Environment B Viviani – Dipartimento di Scienze Farmacologiche e (RECETOX), Masaryk University, Kamenice 753/5, 625 00 Biomolecolari, Università degli Studi di Milano, Italy* Brno, Czech Republic E Fritsche – Leibniz-Institut für umwelt-medizinische Forschung (IUF), Düsseldorf, Germany* The concept of the exposome was first defined in 2005 as ‘the life course environmental exposures, The Adverse Outcome Pathway (AOP) is a from the prenatal period onwards’ [1]. Ever since, it is conceptual framework describing the chain of considered a powerful approach in environmental events leading from the first interaction of any health research, linking exposure and their effects on chemical with a target (molecular initiating event, human health. MIE) to an adverse outcome (AO), generally an apical end-point in accepted regulatory toxicity External exposure to anthropogenic chemicals – testing (EFSA, 2017). According to the OECD including dietary exposure – is well known to play an conceptual framework (OECD 2013, 2014) MIE and important role in human health. So, external exposure AO are sequentially linked by a series of biologically assessment was included in the multidisciplinary plausible and essential key events (KEs) and their workshop held by the National Institute of relationship (key event relationships, KERs) should Environmental Health Sciences (NIEHS) in 2015. On be concordant on dose–response, temporality and it, the exposome was reviewed from diverse research incidence. approaches, promoting so its incorporation within the concept of environmental health [2]. The present AOP describes the linkage between excessive reactive oxygen species (ROS) production In parallel to the exposome, the interest in high- in the mitochondrial respiratory chain and resolution mass spectrometry (HRMS) applications parkinsonian motor deficits, including Parkinson’s in exposure studies has been actively methods disease (PD). Interaction of a compound with applied to target, suspect and non-target screening complexes I and/or III of the mitochondrial analysis for the determination of a broad variety respiratory chain has been defined as the MIE of organic pollutants, residues and substances of that triggers mitochondrial dysfunction leading emerging concern have been applied to a selection to impaired proteostasis, which then causes of environmental [5] and food matrices [6,7]. degeneration of dopaminergic (DA) neurons of However, the advantages of HRMS technology as a the nigrostriatal pathway. These causatively linked tool for the analysis of markers of exposure and its KERs result in motor deficit symptoms typical of applicability to environmental health growing for the parkinsonian disorders including PD and described last decade [3,4]. Full-scan acquisition from LC and in this AOP as an AO. Neuroinflammation has been GC-HRMS studies have not been fully exploited. placed as a late KE, paralleling degeneration of In this work, we present a multitiered approach DA neurons of the nigrostriatal pathway. As DA- for the rapid screening of a large number of releasing neurons of the substantia nigra pars pesticides, drugs, natural toxins and organic compacta (SNpc) projecting into the striatum are pollutants of emerging concern. This relies on the essential for motor control, the KEs also refer to capability of both, GC and LC, coupled to HRMS these two brain structures, i.e. SNpc and striatum. combining target, suspect and non-target screening The weight of evidence (WoE) supporting the techniques. The application of this approach to food relationship between the described KEs is mainly commodities provides quantitative data akin to based on effects observed after exposure to the traditional approaches. Under the scope of external stressor chemical paraquat, which will be used as a exposure assessment, our proposed workflow tool to support the empirical evidence for this AOP. combines the study of environmental and human References biomonitoring exposure pathways to legacy and EFSA, EFSA Journal 2017;15(3):4691. emerging contaminants, facilitating a robust and OECD, 2013. Guidance document on developing and assessing comprehensive understanding and evaluation of the adverse outcome pathways. OECD, Paris. (2013)6:45. exposome. OECD, 2014. User’s Handbook Supplement to the Guidance

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References 37. Assessment of the health risks for the [1] Wild, C. P. Cancer Epidemiol. Biomarkers Prev. 14, 1847–1850 Spanish consumer associated with arsenic, (2005). [2] Cui, Y. et al. Environ. Health Perspect. 137–140 (2016). cadmium and lead content in tuna [3] Mol, H. G. J. et al. Anal. Chim. Acta 935, (2016). [4] Fenaille, F. et al. J. Chromatogr. A 1526, 1–12 (2017). NÚÑEZ LOSADA Ricardo [5] Leendert, V. et al. TrAC – Trends Anal. Chem. 67, (2015). University of Santiago de Compostela [6] Picó, Y. et al. Food Chem. Toxicol. 111, 53–63 (2018). María Ángeles García, María Julia Melgar – Faculty of [7] Castro-Puyana, M et al. TrAC – Trends Anal. Chem. 93, (2017). Veterinary Medicine (Lugo), University of Santiago de Compostela, Spain

The consumption of canned tuna in Spain is first 36. Case study of a exposure assessment in the world rankings. Tuna, as predatory fish, is using various statistical methods to deal subjected to bioaccumulation and magnification with non-detection of pollutants such as metals in its body. Total As, Cd and Pb concentrations in different tuna samples MYUNGSIL Hwang marketed in Galicia (NW Spain) were determined by NIFDS (Korea National Institute of Food and Drug Safety ICP-MS spectrometry. The maximum concentrations Evaluation) observed for Cd and Pb were: 0.045 ppm and 0.091 ppm, respectively, and were below the Eun Jung Kim, You-Gyoung Park, Min Kyoung Seo, maximum levels (ML) set by European regulations. Seungchan Lee, So Won Bak, Yong Eui Koo – NIFDS Because of its high consumption, the risk of chronic effects of all three metals and the risk of cancer for In dietary exposure assessments, it is important to As were calculated based on estimated daily intake handle concentration data that are reported to be (EDI) as suggested by the Joint FAO/WHO, Target below the limit of detection (LOD). Generally, the Hazard Quotient (THQ) and Cancer Risk (CR) models resulting distribution of chemical occurrence values provided by the US-EPA. For these purposes, the is left censored. NIFDS has treated left-censored results of this study were crossed with consumption data with the widely used substitution method data of tuna in Spain provided by the Agencia recommended by international organisations. Española de Consumo, Seguridad Alimentaria y However, this approach has limitations in exposure Nutrición (AECOSAN) through official consumer assessment of some food items that are consumed surveys (ENALIA 1 and ENALIA 2). A 3% level of frequently in our country. For example, aflatoxins total As was assumed to be inorganic As (iAs) for were detected in some food items such as nut calculations, and the previously RfDo proposed for and spices but not detected in other food items Pb was employed. according to the specified domestic monitoring system regularly being carried out. Although The EDIs estimated for adults were far below the the detection rate of aflatoxins was under 5%, its tolerable daily intake (TDI). All THQs calculated were exposure level was over-estimated in the high lower than 1, the limit value. A decreasing degree intake group. Therefore, the handling of left- of magnitude was observed: THQiAs 2.8 × 10–2 > censored data has raised a challenge for NIFDS’s THQCd 2.4 × 10–3 > THQPb 2.2 × 10–4, accounting for a statistical analysis of chemical occurrence data in Total THQ (TTHQ) 3.1 × 10–2. Likewise, the CR did not exposure assessment. In this study, we compared surpass the level assumed to be the acceptable risk methods used to deal with non-detected items: the (10–5) for iAs. substitution method used to date and parametric According to these results, tuna consumption could maximum likelihood (ML) models, the log-probit be considered as safe for human health regarding regression method and the non-parametric Kaplan– these pollutants. Meier (KM) test, which EFSA proposed in 2010 as a more advanced alternative statistical approach. We estimated the parameters of occurrence data such as mean and statistical deviation with these 38. Simultaneous screening of advanced approaches. Based on this study, we will environmental phenolic compounds revise NIFDS’s guideline for appropriate handling of from the South Korean population left-censored distribution of chemical contaminant data in the exposure assessment. PARK You-Gyoung NIFDS (Korea National Institute of Food and Drug Safety Evaluation)

Myung Sil Hwang, Da Hyun Jeong, In Kyung Bae, Min- Jeong Jo, Yong Eui Koo – NIFDS

Phenolic compounds are widely used in cosmetics, personal care products and food packaging ink, which indicates there should be various routes to human exposure. The use of phenolic compounds has raised concerns about the potential health risks associated with its endocrine-disrupting effects.

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In this study, 12-hour urine samples (n = 1,326) Three phycotoxins were detected in the investigated collected from the South Korean adults over 18 years samples: domoic acid (DA), yessotoxin (YTX) and between 2010 and 2012 were analysed. Twenty-seven pectenotoxin-2 (PTX-2). The incidence of toxins deconjugated phenolic compounds (eight alkyl determined in all samples was respectively 29.8% phenols, four chlorophenols, six benzophenones, for DA, 46.6 for YTX and 8.5% for PTX-2. Determined three bisphenols, one triclosan, and five parbens) concentrations were not beyond the EU reference limits. were simultaneously determined from urinary As expected the third scenario was the worst- samples using online solid phase extraction case scenario with DA, YTX and PTX-2 exposures (SPE) and liquid chromatography-tandem mass estimated respectively for general consumers and spectrometry (LC-MS/MS). The analytical method recreational harvesters as follows: 0.000068 and was validated by means of selectivity, linearity, intra- 0.077943 mg DA/kg bw; 0.000003 and 0.014912 mg day and inter-days accuracy and precision. The most YTX/kg bw and 0.000179 and 0.565613 μg PTX-2/kg bw. prevalent compounds in the Korean population were parabens that were detected with 79–100% Analysis of data obtained from the three scenarios rate, followed by t-butylphenol, benzophenone-1 showed more than 100 times higher exposure of and 4-hydroxy benzophenone. Detection rates recreational harvesters to phycotoxins than that of of 16 compounds were less than 50%, and nine general consumers. Nevertheless exposure values compounds among them (n-pentylphenol, did not exceed the recognised acute reference doses. n-hexylphenol, n-heptylphenol, n-octylphenol, These results indicated that more attention should 2,5-dichlorophenol, 2,4,5-trichlorophenol, be paid to wild mussel harvesting and the control of 2,4,6-trichlorophenol, benzophenone-2, bisphenol their supply for consumption. F) were detected less than 20%, which is difficult for statistical determination. This screening method can be suitable for the analysis of a large number of human urinary samples to assess the exposure to 40. Risk assessment of ethyl carbamate environmental phenolic compounds. in major alcoholic beverages in Chinese population

39. Comparison of exposure to marine PINGPING Zhou biotoxins of different population groups China National Centre for Food Safety Risk Assessment in Bulgaria Zhaoping Liu – China National Centre for Food Safety Risk Assessment PETEVA Zlatina Medical University, Varna Objective: To assess the health risk of exposure to ethyl carbamate (EC) from alcoholic beverages in Bernd Krock – Alfred Wegener Institute, Helmholz Zentrum für Polar- und Meeresforshung, Chemische Ökologie, am Chinese adult drinkers. Handelshafen 12, 27570 Bremerhaven, Germany Methods: The simple distribution method was Stanislava Georgieva, Anelia Gerasimova, Mona introduced in dietary exposure assessment Stancheva, Lubomir Makedonski – Medical University, of ethyl carbamate from alcoholic beverages Varna, Bulgaria consumed by the population aged 15 and above. Phycotoxins are produced by some phytoplankton The human dietary intake of EC via alcoholic species and accumulate in filter feeding bivalves. beverages was estimated based on nine provinces Once ingested they could pose serious risk to (municipalities) of alcoholic beverages consumption human health. data in combination with national food safety risk monitoring occurrence data in China. The occurrence The aim of the study was to determine the data comprises the EC contents of different alcoholic occurrence of marine biotoxins in wild and farmed beverages including distilled spirit, yellow wine, mussels Myrtillus galloprovincialis in the year 2017 wine, beer and liqueur. The risk assessment was in Bulgaria, and to estimate the exposure of two conducted using the Margin of Exposure (MOE) adult population subgroups: general consumers approach with benchmark doses obtained from and recreational harvesters through consumption of dose–response modelling of animal experiments. mussels. Results: The overall average EC content of alcoholic Wild and farmed mussels (N = 47) from two beverages was 61.1 μg/kg (ND ≈5,170 μg/kg) and harvesting periods in 2017: spring and autumn the median was 21.4 μg/kg, showing obvious were analysed with multiphycotoxin method positive skewed distribution. Yellow wine had the using LC-MS/MS. Exposure assessment for the two highest average EC content up to 125.1 μg/kg. The population subgroups were obtained through estimated average dietary exposure to EC was integration of levels established in phycotoxins about 62.8 and 217.9 ng/kg bw per day for alcoholic analysis combined with the food consumption data beverages consumers and high consumption of population groups and body weight (bw). Three population (exposed to P95) respectively. The scenarios were evaluated based on: (1) data from MOEs of alcoholic beverage consumers and high mean concentrations of positive samples; (2) data consumption populations exposed to EC were from mean concentration of all analysed samples calculated to range between 1,000 and 5,000 (less where ‘non-detect’ was replaced by LOD/2; and (3) than 10,000), indicating a health concern. According maximum concentration found.

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to the individual distribution of EC exposure, the 42. In silico toxicity prediction for ethoxyquin proportion of individuals with exposure to MOE of and its transformation products. less than 10,000 for the exposure of alcohol drinkers was high as 43.6%. RASINGER Josef Daniel Conclusion: Given the dose–response relationship Institute of Marine Research (IMR), Bergen, Norway; EFSA between the EC doses used in the animal experiment EU-FORA Fellow at the BfR and the tumour incidences, it is concluded that EC exposure poses a significant cancer risk for the F Frenzel – Federal Institute for Risk Assessment (BfR), alcohol-drinking population in China. Berlin, Germany S Merel, M Berntssen, R Ørnsrud – IMR, Bergen, Norway A Lampen, A Braeuning – Federal Institute for Risk Assessment (BfR), Berlin, Germany 41. Health risk assessment of Cu and Mo in vegetables grown under the impact Ethoxyquin (EQ; 6-ethoxy-2,2,4-trimethyl-1,2- of Kajaran’s mining complex dihydroquinoline) has been used as an antioxidant in feed for pets, livestock and aquaculture. Concerns regarding the safe use of ethoxyquin as PIPOYAN Davit an antioxidant feed additive have recently arisen Centre for Ecological-Noosphere Studies National due to its potential conversion into a series of Academy of Sciences, RA transformation products (TPs). Using travelling- Nicolo Merendino (Associate Professor), Armen wave ion mobility spectrometry (TWIMS) coupled Saghatelyan (Full professor) to quadrupole time-of-flight mass spectrometry (QTOFMS) at the Institute of Marine Research (IMR) Mining industry is one of the priority branches of in Norway, 27 EQ TPs were identified in oxidation Armenia’s economy. Activity of mining complexes experiments; 25 of these were detected in fish feed without treatment facilities, abandonment of tailings and 24 in fish from EQ exposure experiments. In dams and many other violations have a grave the present work in the course of an EFSA EU-FORA impact on the environment (Saghatelyan et al. 2010). fellowship programme we used a computational Transfer of trace aspects from soil to plant cannot be toxicity pipeline developed and implemented at underestimated as it is the major pathway of human the Federal Institute for Risk Assessment (BfR) in exposure. For this purpose, firstly, trace element Germany to predict in silico the toxicity of EQ TPs. contents in soils and plant species were determined, The data obtained facilitates the prioritisation of afterwards, transfer factor (TF) and estimated daily EQ TPs according to their theoretical toxicities and intakes (EDI) were calculated. highlights the compounds of most concern that need to be analysed further using in vitro or in vivo Topsoil sampling was performed according to models of toxicity. It is expected that the present Standard Operation Procedures (SOPs). Locally work will aid current efforts to fill data gaps in the grown and widely consumed plant samples were assessment of the exposure and the safety of EQ and collected from the same soil sampling points its TPs for animals, consumers and the environment. according to WHO and FAO requirements (WHO/ FAO 2008). Overall, 12 samples of soil and 32 samples of vegetables (potato, carrot, bean, fennel and pumpkin) were collected. Concentrations 43. Testing the TTC using EFSA’s of trace elements (Cu and Mo) in soil and plant OpenFoodTox database samples were estimated using atomic absorption spectrophotometry. This study included the REILLY Linda development of a food frequency questionnaire (FFQ). EFSA

In the present study the obtained results indicated Georges Kass, Rositsa Serafimova, Jean-Lou Dorne, that TF values varied from element to element Daniela Maurici – EFSA depending on type of vegetable. The smallest value of TF was obtained for Cu (carrot) and the highest Improving analytical methodologies have led to the one for Mo (fennel). Soil to plant transfer factors were detection of an increasing number of compounds less than 1. Lower values indicated the poor response present at low concentrations but with insufficient of plants towards element uptake. However, it toxicity data for risk assessment. Alternative methods should be stressed that EDIs of Cu and Mo for all such as the Threshold of Toxicological Concern (TTC) investigated vegetables exceeded the health-based approach could be used as a prioritisation tool for a guidelines values. large cohort of compounds requiring toxicity testing. The TTC concept integrates data on exposure, Furthermore, detailed investigations need to be structure, toxicity and metabolism to identify a safe performed for the overall assessment of health risks, exposure threshold value. TTC threshold values were taking into consideration not only adverse health originally derived from a non-cancer dataset of 613 effects posed by more than one toxic trace element, compounds often criticised for not representing but also other exposure pathways (inhalation, the ‘world’ of chemicals. So, there is an expressed dermal, etc.). need to expand the current TTC dataset. This study aims to test the TTC concept using EFSA’s new OpenFoodTox database. The TTC concept was

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applied in silico using the OECD’s QSAR toolbox tributyl citrate (ATBC), a common plasticizer used to categorise over 300 compounds from EFSA’s in the manufacture of packaging materials was database into one of three classes, under the Cramer determined using a Total Diet Study (TDS) approach decision tree. These three classes are reflective of and was also estimated using the FACET exposure toxicity and identify low (class I), moderate (class II), tool. and high (class III) toxicity. The lognormal cumulative The results obtained with the TDS approach agree distributions of reference points for compounds closely with those estimated with the FACET were plotted for each of the three classes. The exposure model. So, for example the mean dietary fifth percentile of each cumulative distribution exposures of ATBC were 1.01 µg/kg bw/day for the was used to derive a TTC value by applying an group 1–3 years; 2.01 µg/kg bw/day for the group uncertainty factor of 100, and factoring in average 3–9 years and 1.27 µg/kg bw/day for the group 10–17 human weight. EFSA’s TTC values were used to years. Those obtained with the FACET tool were 1.5 compare against the original threshold values for µg/kg bw/day for the group 1–3 years; 1.52 µg/kg bw/ protectiveness. Results showed the threshold value day for the group 3–9 years and 0.9362 µg/kg bw/day derived for Cramer class III was protective of the for the group 10–17 years. In all cases, mean dietary original threshold value. However, Cramer class I fell exposures to ATBC were below the tolerable daily below the original threshold value, while Cramer intake (TDI) of 1.0 mg/kg body weight set by the EU class II had too few compounds to carry statistical for ATBC. weight. Our analysis shows that the TTC approach is protective for chemicals pertinent to food safety. Funding However, further expansion of the TTC dataset would The study was financially supported by the ‘Ministerio de be beneficial for refining TTC values. Economía y Competitividad’, ‘Fondo Europeo de Desarrollo Regional (FEDER) and by ‘Agencia Estatal de Investigación’ ref. no. AGL2015-69609-P ‘MIGRAEXPO’ (MINECO/FEDER, UE). Key words: exposure assessment, TDS, ATBC, FACET exposure model 44. Food packaging contaminants: estimating dietary exposure 45. Metals in Undaria pinnatifida RODRÍGUEZ BERNALDO DE QUIRÓS Ana University of Santiago de Compostela RUBIO Carmen Veronica García Ibarra, Raquel Sendon, Department of Universidad de La Laguna Analytical Chemistry, Nutrition and Food Science, Faculty Soraya Paz, Dailos González-Weller, Arturo Hardisson, of Pharmacy. E-15782, Santiago de Compostela, Spain Consuelo Revert, Ángel Gutiérrez – Universidad de La Juana Bustos, Maria Luisa Lomo – National Food Centre, Laguna Spanish Agency for Consumer Affairs, Food Safety and Nutrition. 28220 – Majadahonda, Spain There is no doubt that the dietary consumption Perfecto Paseiro – Department of Analytical Chemistry, of algae that has been traditionally consumed in Nutrition and Food Science, Faculty of Pharmacy. E-15782, Asia is expanding to Europe. Undaria pinnatifida Santiago de Compostela, Spain or wakame, belonging to the brown algae, is one of the most widely consumed algae, especially for The safety of packaging materials is of great concern its beneficial properties. Numerous studies have for food safety as low-molecular-weight substances shown that U. pinnatifida has a high capacity for can migrate from the packaging into the food and metal absorption, which is of both nutritional and can cause harmful effects to human health through toxicological interest. However, its full metal profile dietary exposure. Exposure assessment is one of the has been little studied. essential aspects in the risk assessment process. To estimate the exposure to migrated substances The objective of this study is to determine the from food-contact materials several methods have levels of 20 metals (Na, K, Mg, Ca, Fe, Zn, Cu, Cr, B, been applied. In the European Union, a conservative Ba, Pb, Cd, Al, Sr, Li, Ni, Co, Mn, Mo and V) in 25 U. assumption is adopted, namely a person of 60 kg pinnatifida samples from two geographical areas body weight consumes daily 1 kg of food packed in (Asia n = 10; Europe n = 15), using Inductively Coupled a cubic container of 6 dm2. The exposure can also Plasma–Optical Emission Spectrometry (ICP–OES) be estimated more realistically by combining the to evaluate the nutritional value and toxicological migrated substance concentration in food and the risk of its metal content based on the recommended consumption data obtained from consumer surveys. consumption of U. pinnatifida (5 g dehydrated More refined approaches have also been used; algae/day) and the Recommended Daily Intake and as part of the European Project FACET (Flavours, maximum tolerated intakes. Additives and Food-Contact Materials Exposure Task) a probabilistic modelling tool to estimate While samples of U. pinnatifida from Asia have the exposure to migrated substances from food- the highest concentrations of elements such as Na contact materials was designed. This model allows (28.2 ± 2.71 g/kg dry weight) or Fe (58.8 ± 17.3 mg/ the exposure assessment of migrated substances kg dw), the samples from the European coastal using information on packaging (use, composition), waters contain the highest levels of Zn (40 ± 32 mg/ consumption data, etc. kg dw). Among the metals of toxicological interest, Al stands out with levels of 31.5 ± 17.3 mg/kg dw in In the present work, the dietary exposure from algae from Europe that are higher than those found cereal-based foods in plastic packaging, to acetyl in samples from Asia (20.0 ± 4.4 mg/kg dw). The

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highest contents of Cd (1.11 ± 0.33 mg/kg dw) were analytical data distribution and cumulative detected in algae from Asia, and were much higher intake over time into the definition than those found in algae from Europe. Significant of ‘safety-based guidance values’ for differences were found (P <0.05) in the contents of Al, B, Ba, Cd, Fe, K, Li, Mg, Mn and Zn between algae chemical contaminants in raw materials from Asia and those from Europe. SCHOLZ Gabriele Considering a consumption of 5 g/day of U. Nestlé Research Centre Lausanne pinnatifida from Asia, the consumer would be exposed to a metal intake that contributes 23% of Mireille Moser, Thomas Stroheker, Paolo Mazzatorta – the TWI of Cd, which is set at 2.5 μg Cd/kg bw/week. Nestlé Research Centre Lausanne, Switzerland These new data highlight the need to monitor the metal content of edible algae, to consider algae as a We have recently developed a globally applicable new dietary source of metals and include maximum scientific tool for the assessment and prioritisation permitted levels of toxic metals in this new group of of chemical hazards in food raw materials. In the foods formed by algae. tool, we defined so-called safety targets (STs) as concentrations of chemical contaminants in raw materials below (or at which) no safety concern is foreseen when ingested over a lifetime in the 46. How EFSA contributes to ensure that context of overall exposure. Average concentrations European consumers are protected of contaminants are used to derive STs along from pesticide residues in food – the MRL with average food intake data and established review process health-based guidance values (HBGVs). In reality, contaminant levels in a particular raw material can incidentally exceed ‘safety targets’. We have SANTOS Miguel recently asked the question how such variability EFSA in occurrence in consumption over time can be Luis Carrasco Cabrera, Lucien Ferreira, Luna Greco, Renata incorporated into the concept of ‘safety-based Leuschner – EFSA guidance values’ (SBGVs), making sure that over time, food safety is not compromised even with The cooperation between EFSA, Member States and incidental deviation. This is based on the assumption the European Commission is essential to ensure that that occasional exposures above the HBGV do not European consumers are protected from pesticide in general represent a health concern (e.g. seasonal residues in food. In the European Union (EU) plant increases in mycotoxin concentrations in cereals), protection products can only be placed on the as long as average exposure to a contaminant over market or used with prior authorisation. Regulation a relevant period of time remains below the HBGV, (EC) No. 396/2005 covers all matters related to legal and extreme exposures potentially leading to acute limits (maximum residue levels (MRLs)) for pesticide effects are excluded. residues in food and feed. The present work describes the development of Maximum residue level means the upper legal level a statistical tool, based on the distribution of the of a concentration for a pesticide residue in or on contaminant in raw material and resampling food or feed set in accordance with this Regulation, technique, to calculate SBGVs that take these based on good agricultural practice (GAP) and the aspects into account and that can be used as lowest consumer exposure necessary to protect an input for quality management of chemical vulnerable consumers. For crops grown outside the contaminants in raw materials. The tool is flexible EU, MRLs are set on the request of the exporting and applicable to different chemical contaminants country (important tolerances) and are also assessed and datasets and case studies are in progress to by EFSA. evaluate and verify its protectiveness for consumers. Following approval of an active substance in the EU, all GAPs (detailing the quantity, frequency and plant growth stage of the pesticide applied) authorised in the different Member States are assessed by EFSA in a process called MRL review, under Article 12 of Regulation (EC) No. 396/2005. This process is performed in cooperation with Member States, which are collecting and reporting the GAPs authorised in their countries and are evaluating the data supporting these GAPs. EFSA then performs a dietary risk assessment to ensure that MRLs are safe for consumers. If the risk assessment provided by EFSA does not identify any unacceptable risks to consumers, the MRLs can be set at the European level as legal limits in food by the European Commission.

47. A statistical approach to integrate

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48. Guidance on risk assessment of Dehydroacetic acid was measured by a validated the application of nanoscience and HPLC method according to Commission Decision nanotechnologies in the food and feed 2002/657/EC criteria in terms of specificity, linearity, precision and accuracy, limit of detection and limit of chain. Part 1: Human and animal health quantification. The method was successfully applied to about 160 samples of commercial cheese coatings SCHOONJANS Reinhilde and related treated cheeses collected in Italy during EFSA 2017. The overall results demonstrated that about 40% of the investigated cheese coatings contained Berrak Eryasa, Reinhilde Schoonjans – EFSA dehydroacetic acid, ranging from 0.010% to 2.5% w/w, evidencing illicit employment of this substance. The European Food Safety Authority has produced Moreover, about 25% of treated cheeses contained guidance on human and animal health aspects dehydroacetic acid, from 5 to 250 mg/kg, proving (Part 1) of the risk assessment of nanoscience and transfer of this substance from crust to cheese. nanotechnology applications in the food and feed After this investigation, alert messages were sent chain. It covers the application areas within EFSA’s to the Rapid Alert System for Food and Feed of the remit, e.g. novel foods, food-contact materials, food/ European Commission (RASFF) and products were feed additives and pesticides. The Guidance takes withdrawn from the market. account of the new developments that have taken place since publication of the previous Guidance in 2011. It specifically elaborates on physicochemical characterisation of nanomaterials in how to 50. Role of OLIG2 expression in motor establish whether a material is a nanomaterial, neurone progenitor cells in the differentiation the key parameters that should be measured, of human-induced pluripotent stem cells the methods and techniques that can be used to motor neurons for Botulinum neurotoxin for characterisation of nanomaterials and their determination in complex matrices. It also details potency testing the aspects on exposure assessment and hazard identification and characterisation. In particular, SEEGER Bettina nanospecific considerations on in vivo/in vitro University of Veterinary Medicine Hannover Foundation toxicological studies are discussed and a tiered Maren Lück – Institute for Food Toxicology, Department framework for toxicological testing is outlined. of Food Toxicology and Replacement/Complementary Depending on the initial tier results, studies Methods to Animal Testing, University of Veterinary may be needed to investigate reproductive and Medicine Hannover, Foundation, Hannover, Germany developmental toxicity, immunotoxicity, allergenicity, Britt-Maren Schjeide – Institute of Nutritional Science, neurotoxicity, effects on gut microbiome and Department of Nutritional Biochemistry, University of endocrine activity. It also touches upon the possible Potsdam, Nuthetal, Germany use of read across to fill data gaps, in vitro digestion, Gerhard P Püschel – Institute of Nutritional Science, toxicokinetics, genotoxicity, as well as general Department of Nutritional Biochemistry, University of issues on in vitro testing of nanomaterials. The Potsdam, Nuthetal, Germany potential use of integrated testing strategies and Bettina Seeger – Institute for Food Toxicology, Department the knowledge of modes/mechanisms of action are of Food Toxicology and Replacement/Complementary also discussed. The Guidance proposes approaches Methods to Animal Testing, University of Veterinary Medicine to risk characterisation and uncertainty analysis, and Hannover, Foundation, Hannover, Germany provides recommendations for further research in Botulinum neurotoxins (BoNTs) are potent this area. neurotoxins that are used as therapeutics. An ethically questionable mouse lethality assay is widely used to test BoNT activity. The aim of the 49. Food additives Italian official control: project is to develop a cell-based toxicity assay to dehydroacetic acid in cheese and cheese replace the animal experiment. To this end, induced coating human pluripotent stem cells (hiPSCs) need to be differentiated into motor neurons, the natural target of BoNTs. SCORDINO Monica Ministry of Agriculture and Foodstuff Policies OLIG2 plays a pivotal role in the dorsal–ventral patterning of the motor neurone progenitor cells F Lazzaro, MA Borzì, L Sabatino, P Traulo, G Gagliano – during differentiation, as only cells expressing OLIG2 Italian Ministry of Agriculture, Foodstuffs and Forestry are able to differentiate to mature motor neurons. Policies, Department of Central Inspectorate for Fraud Repression and Quality Protection of Agri-food Products, hiPSCs were cultured according to three different Laboratory of Catania differentiation protocols using small molecules to direct cellular differentiation. OLIG2 expression was This work reports the occurrence of dehydroacetic quantified at the progenitor cell stage to correlate acid in cheese and cheese coatings collected in Italy the yield of motor neurons, BoNT receptor structures during Agricultural Ministry Official control in 2017. and BoNT targets to subsequently optimise the Dehydroacetic acid is an antimicrobial substance protocols. not allowed to be used in EU countries as a food additive, with unknown effects on human health.

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OLIG2 and NKX6.1 expression in the progenitor 2. pooling of foods according the consumer survey data; cell stage correlated with the differentiation 3. the potential migrated substances previously into adult motor neurons, which was verified by identified in the packaging were determined in confirming the expression of motor neurone pooled foods; markers MNX1, ISL1 and CHAT by RT-qPCR and by immunocytochemistry. 4. the exposure was estimated by using migrated substance concentration data in food and BoNTs enter motor neurons by the interaction consumption data. with receptor structures, namely SYTI/II, SV2A/B/C, and then cleaves SNARE proteins involved in The method was successfully applied to estimate neurotransmitter release, i.e. STX1A/B, VAMP1/2 and the dietary exposure to chemicals from cereal-based SNAP25. The expression of the motor neurone markers food packed with plastic materials in the Spanish appears not to correlate with the expression of the population. Different compounds such as acetyl receptor structures and SNARE proteins. This disparity tributyl citrate (ATBC), diethyl phthalate (DEP), in expression levels must be investigated while the diisobutyl phthalate (DIBP) and bis (2-ethylhexyl) differentiation protocols are further optimised. As the adipate (DEHA) among others were identified in uptake of BoNTs also depends on gangliosides as the packaging materials and the exposure to these co-receptors, their cell surface concentration must contaminants were estimated by using the Spanish be determined and the expression studies must be national dietary survey Enalia. So, the mean dietary complemented by functional assays for uptake of the exposure to DEP was 0.179 mg/kg bw/day for people different BoNT serotypes. aged 10–17 years and 0.332 mg/kg bw/day for people Funding aged 3–9 years, or for example the mean dietary exposure to DEHA was 0.365 mg/kg bw/day for The MoNLightBoNT-Assay development is funded by a grant from the German Federal Ministry of Education and Research people aged 6–11 months and 0.104 mg/kg bw/day (FKZ 031L0132A/B). for people aged 1–3 years. This approach is a simple and useful screening tool for estimating dietary exposure to chemicals from the packaging. 51. Exposure to chemicals from food Funding packaging materials: a total diet study The study was financially supported by the ‘Ministerio de Economía y Competitividad’, ‘Fondo Europeo de Desarrollo approach Regional (FEDER) and by ‘Agencia Estatal de Investigación’ Ref. No. AGL2015-69609-P ‘MIGRAEXPO’. (MINECO/FEDER,UE). SENDÓN Raquel Key words: exposure assessment, TDS approach, packaging contaminants University of Santiago de Compostela

Veronica García Ibarra, Ana Rodríguez Bernaldo de Quirós – Department of Analytical Chemistry, Nutrition and Food Science, Faculty of Pharmacy, E-15782, Santiago de 52. Deoxynivalenol vs lactic acid bacteria: Compostela, Spain a biodegradation competition Juana Bustos, Maria Teresa Nieto – National Food Centre, Spanish Agency for Consumer Affairs, Food Safety and SPAGGIARI Marco Nutrition, 28220 – Majadahonda, Spain University of Parma, Department of Food and Drug Perfecto Paseiro – Department of Analytical Chemistry, Nutrition and Food Science, Faculty of Pharmacy, E-15782, Martina Cirlini, Benedetta Bottari, Valentina Berinini, Santiago de Compostela, Spain Dall’Asta Chiara, Gianni Galaverna – Department of Food and Drug, University of Parma, Parco Area delle Scienze Nowadays most foods are marketed as packaged 95/A, 43124 Parma, Italy and, as a result of the interaction between the packaging and the food, migration of packaging The mycotoxin deoxynivalenol (DON) is a secondary components can occur. Therefore packaging metabolite produced by the plant pathogen materials are a potential source of contamination Fusarium spp. It causes serious problems in cereal and are subject to risk assessment. crops, because of its toxicity in humans and livestock, and it is also responsible for huge economical The Total Diet Studies (TDS) are widely used to losses. Biological methods that are specific for provide dietary exposure data to both beneficial degradation, biotransformation and/or reduction substances and contaminants. The essential steps of the mycotoxin content in grains, feed and food of a TDS are the following: should be representative using microorganisms have gained growing interest of the whole diet; pooling of foods; and foods are over the last few years. In this context, lactic acid analysed as consumed. bacteria (LAB) represent a promising group and are In the present work a methodology based on a indicated as ‘Generally Recognised as Safe’ (GRaS) TDS to evaluate the exposure to chemicals from by the Food and Drug Administration of the United food packaging materials was developed. The States (USFDA) and by the EU Scientific Committee experimental design involves the following steps: on Animal Nutrition (SCAN). 1. a non-target analysis was conducted to identify This study investigated the ability of two lactic potential migrated substances, for that purpose gas acid bacteria (LAB) strains to remove DON. LAB chromatography-mass spectrometry (GC-MS) was strains, L. plantarum Z1 and L. rhamnosus 2411, applied; isolated from various sources, were screened in vitro

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to evaluate their capability to reduce mycotoxin by gas chromatography-tandem mass spectrometry concentrations (100 µg/ml). Two protocols were (GC-QqQ-MS/MS) for the presence of deoxynivalenol tested to better understand the mechanism of (DON), 3-acetyldeoxynivalenol (3AcDON), putative biodegradation. In the first protocol, 15-acetyldeoxynivalenol (15AcDON), fusarenon-X, bacteria cells were inoculated into medium nivalenol, HT-2 toxin, T-2 toxin, diacetoxyscirpenol, containing mycotoxins and then incubated, neosolaniol and zearalenone (ZEA). Exposure of while in the second, grown cultures were pelleted the Romanian adult population was assessed by and separated from the growth medium before combining national consumption data of wheat incubation with the mycotoxins. Positive (non- products (365 g kg–1 body weight day–1) with the inoculated MRS with added DON) and negative analytical results, supposing two scenarios: one (mycotoxin-free MRS broth) controls were always underestimating (lower bound – LB) and another included in the experimental design. Samples were one overestimating (upper bound – UB) exposure. incubated at 37°C for 48 h. DON content before The estimated daily intake (EDI) values calculated and after the fermentation process was monitored were compared with the available tolerable daily using an UHPLC-MS/MS method. The mycotoxin intake (TDI) values established or proposed (EFSA, content decreased after the fermentation process, 2011; JECFA, 2001). The highest EDI values were more particularly when the second protocol was observed for the sum of DON+3AcDON+15AcDON applied. Therefore, this study may represent a (669 ng kg–1 body weight day–1 at LB, and 689 ng starting point in selecting the most efficient LAB kg–1 body weight day–1 at UB), being lower than the strains for detoxifying a particular mycotoxin and TDI set (1,000 ng kg–1 body weight day–1). For ZEA, represents a useful tool to ensure greater safety in a maximum EDI of 26 ng kg–1 body weight day–1 fermented foods. Furthermore, attention should also was calculated, below the TDI set (200 ng kg–1 body be paid to the method of toxin reduction. In fact, it weight day–1). These results were obtained using has been shown that in DON reduction of the 12,13 data for a wide category of wheat-based foods and epoxide group or oxidation of the hydroxyl group on are part of the first study estimating exposure to carbon 3 by the microbial strains causes decreased mycotoxins of the Romanian population. Although toxicity. Nevertheless, the exact mechanism of toxin all the exposures assessed were lower than the TDIs, reduction warrants further investigation. the results indicated the need for more studies Key words: deoxynivalenol (DON), lactic acid bacteria (LAB), regarding risk assessment of mycotoxins. biodegradation, reduction ability References EFSA (2011). Scientific Opinion on risks for animal and public health related to the presence of T-2 and HT-2 toxin in food and 53. Multiple Fusarium mycotoxins in wheat- feed. EFSA Journal; 9(12):2481. JECFA (2001). Evaluation of certain mycotoxins in food. WHO based products: occurrence and exposure Technical Report Series, 56th Report. Geneve. assessment for the Romanian population Key words: deoxynivalenol, EDI, mycotoxins, wheat products

STANCIU Oana Maria Department of Bromatology, Hygiene, Nutrition, Faculty 54. Acrylamide in food: official control of Pharmacy, Iuliu Haţieganu University of Medicine and dietary exposure assessment in Cyprus and Pharmacy, 6 Louis Pasteur, 400349, Cluj-Napoca, Romania; Laboratory of Food Chemistry and Toxicology, Faculty of Pharmacy, University of València, Av. Vicent STAVROULAKIS Georgios Andrés Estellés s/n, 46100, Burjassot, València, Spain State General Laboratory (SGL)

Cristina Juan – Laboratory of Food Chemistry and Toxicology, Demetris Kafouris, Maria Christofidou, Xenia Iakovou, Faculty of Pharmacy, University of València, Av. Vicent Andrés Eftychia Christou, Lefkios Paikousis, Maro Christodoulidou, Estellés s/n, 46100, Burjassot, València, Spain Stelios Yiannopoulos – Risk Assessment Unit, State General Laboratory (SGL), Ministry of Health, Nicosia, Cyprus Doina Miere – Department of Bromatology, Hygiene, Nutrition, Faculty of Pharmacy, Iuliu Haţieganu University Acrylamide (AA) is present in a variety of foods of Medicine and Pharmacy, 6 Louis Pasteur, 400349, Cluj- Napoca, Romania consumed by children and, due to its possible harmful effects, the results of official monitoring Houda Berrada – Laboratory of Food Chemistry and Toxicology, Faculty of Pharmacy, University of València, Av. for the period 2007–2016 were used for dietary Vicent Andrés Estellés s/n, 46100, Burjassot, València, Spain exposure assessment of adolescents in Cyprus. Felicia Loghin – Department of Toxicology, Faculty of The determination method is based on a single Pharmacy, Iuliu Haţieganu University of Medicine and extraction step with water, followed by the clean- Pharmacy, 6 Louis Pasteur, 400349, Cluj-Napoca, Romania up of the extract using solid phase extraction Jordi Mañes – Laboratory of Food Chemistry and Toxicology, columns and, finally, the determination of AA using Faculty of Pharmacy, University of València, Av. Vicent Andrés ultrahigh performance liquid chromatography Estellés s/n, 46100, Burjassot, València, Spain with tandem mass spectrometry. The method performance characteristics were determined A dietary exposure assessment to mycotoxins was after spiking blank samples. The mean recoveries conducted for the Romanian population using the in spiked coffee samples, potato chips, breakfast contamination data of various wheat products for cereals and crispbread ranged from 93% to 99%, with human consumption. Wheat-based foods (n = 181) relative standard deviations lower than 5% for both commercialised in Romania, including flour, bread, repeatability and reproducibility conditions. The biscuits, breakfast cereals and pasta, were analysed estimated limits of detection and quantification of

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the method were 10 and 32 μg kg–1, respectively. The the largest part in the consumer’s diet and that method was used for monitoring AA in 473 samples tetracycline residues can also be present in other for the period 2007–2016. AA amounts ranged from food types such as fruits, vegetables, dairy products, <32 to 2,450 μg kg–1. In total, 393 samples (83%) were there is a health risk that the estimated daily intake contaminated with AA, but only 12% of the samples of this drug can exceed the defined ADI level. exceeded the indicative values of the EU legislation. Foods with the highest mean AA amounts were –1 –1 potato crisps (642 μg kg ), french fries (383 μg kg ) 56. Risk assessment of trace elements in and biscuits (353 μg kg–1). fruits and vegetables of Kapan, Armenia Using the ImproRisk model, the mean and 95th percentile dietary intake values, based on mean STEPANYAN Stella –1 AA concentrations, were 0.8 and 1.8 μg kg bw per Informational Analytical Centre for Risk Assessment of day, respectively. The estimated levels of dietary Food Chain, CENS National Academy of Sciences, RA, exposure to AA are not of concern with respect to Yerevan, Armenia neurotoxicity. However the margins of exposure (MOEs) indicate a concern for carcinogenicity. Potato Davit Pipoyan, Meline Beglaryan – Informational fried products (45%), fine bakery ware (biscuits, rusks, Analytical Centre for Risk Assessment of Food Chain, CENS crackers, pastries and cakes) (21%) and potato chips National Academy of Sciences, RA, Yerevan, Armenia (14%) contributed the most to overall AA exposure. Food is a major source of toxic trace element intake for people, so contamination of food by trace elements is a global issue. Fruits and vegetables, 55. Risk assessment of tetracycline residues in particular, constitute a fundamental part of a in chicken meat, Yerevan, Armenia balanced diet. They are consumed all over the world, and particularly in Armenia, where the consumption STEPANYAN Seda of fruits and vegetables is approximately five times Centre of Ecological-Noosphere Studies of National higher than the WHO/FAO recommended amount. Academy of Science, Republic of Armenia Hence, the estimation of dietary intakes of trace elements through fruit and vegetable consumption David Pipoyan – Head of Informational Analytical Centre is of particular importance in Armenia for observing for Risk Assessment of Food Chain, of CENS NAS, RA the underlying health risks to local people. This study Nicolo Merendino – Expert at Department of Ecological was carried out for assessing the dietary exposure and Biological Sciences (DEB), Laboratory of Cellular and of toxic trace elements via the intake of fruits Molecular Nutrition, Tuscia University and vegetables sold in markets of Kapan, a town located in the largest mining region of Armenia. Objectives: There is an extensive use of antibiotics, For studying the consumption patterns of fruits especially tetracycline residues in poultry to prevent and vegetables among the local population, a food various diseases and to enhance animal growth. frequency questionnaire (FFQ) was developed and Inappropriate use may result in the presence utilised to carry out surveys. The concentrations of of antibiotic residues in poultry meat at unsafe Pb, As, Cd, Hg, Ni, Cr, Mo, Cu and Zn in different types concentrations that can adversely affect public of fruits and vegetables were determined. Moreover, health. The aim of the current study was to evaluate by combining concentration data with consumption the risk of tetracycline residue intake through local data, the estimated daily intake (EDI) and target and imported poultry meat consumption among hazard quotient (THQ) were calculated for a priori the Yerevan population. specified trace elements. Eventually, the obtained Methods: The concentration of tetracycline values were compared with health-based guidance residues was determined using enzyme-linked values. The obtained results indicated that although immunosorbent assay analysis. Poultry consumption the estimated daily intakes of trace elements for amount was determined based on a food frequency each studied fruits and vegetables did not exceed questionnaire conducted in Yerevan. health-based guideline values, for the combined consumption of these food items estimated Results: The average concentration of tetracycline cumulative daily intakes exceeded reference doses in local and imported poultry meat was determined for Cu and Mo. to be very negligible and 0.01 mg/kg, respectively. The latter is slightly greater than the maximum allowable level set by the customs union. Conclusions: Daily exposure to tetracycline through poultry meat using average daily chicken consumption was estimated to be 0.001 mg/kg bw/ day. Risk characterisation of dietary exposure to tetracycline residues via imported poultry intake among Yerevan population showed that, according to the standard dietary recommendation of poultry (200 grams per day), consumers can receive approximately 7% of acceptable daily intake. Taking into consideration that imported poultry constitutes

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57. A tool to integrate scientific risk While it is entirely appropriate to set an ARfD assessment principles into the management for acutely toxic molecules (such as neurotoxic and prioritisation of chemical contaminants insecticides), ARfDs are increasingly set for chemicals of low acute toxicity. Numerous study endpoints are in raw materials used, of which many appear not appropriate against the protection goal. The purpose of this analysis was STROHEKER Thomas to review the basis on which ARfDs were set to better Nestlé Research Centre, Vers-chez-les-Blanc, Switzerland understand if these were necessary and relevant. A 130 ARfDs set of agrochemicals was analysed for Gabriele Scholz, Mazzatorta Paolo – Nestlé Research the study type used and effects driving the point of Centre, Vers-chez-les-Blanc, Switzerland departure. 26 were based on acute (neuro-)toxicity We have developed a new globally applicable studies and the majority was deemed appropriately scientific tool for the assessment and prioritisation set. Developmental toxicity studies were used of chemical hazards in food raw materials. The tool extensively (70 of 130 ARfDs; with rabbit used twice is based on the four principles of risk assessment, as often as rat). While rat developmental toxicity considering overall exposure to chemical studies were mostly appropriately interpreted, contaminants. From these calculations, and the 85% of the ARfDs based on rabbit studies appear application of a decision tree, the tool provides questionable or irrelevant to acute effects. Similar the user with a level of risk (or ‘likelihood to cause ratios between appropriate and questionable/ harm’). For each individual contaminant, a severity irrelevant were identified in ARfDs based on rat grade was set according to the use of an additional repeated dose studies (3 of 8) and generational decision tree based on toxicological characteristics studies (3 of 10). Dog repeated dose studies of the chemical (e.g. carcinogenicity, reprotoxicity appeared to provide a clearer basis with about 50% or developmental toxicity). Both decision trees of the ARfDs set based on appropriate effects (8 of imply scientific, objective and transparent selection 16). In conclusion, ARfDs are set most appropriately criteria. Taken together, severity and risk are when the effects are truly acute in nature (acute positioned in a matrix informing on the prioritisation toxicity, acute clinical signs in dogs). ARfDs derived level of each combination of chemical hazard and from repeated dose, rat developmental toxicity or raw material. The proposed model is intended to be generational studies are often set conservatively and adequately protective for the consumer’s health, as it appears questionable if assignment of an ARfD it considers a conservative food intake scenario, as was necessary, in particular if the LD50 was high. A well as various sources of contaminant exposure. The high rate of inappropriate ARfDs are set based on model’s design is flexible and can easily be adapted rabbit developmental toxicity studies, indicating to the needs of different food product categories that the rabbit as a test system may not be well and scenarios. The model was tested using several understood for this purpose. examples, the results of which are consistent with existing data in the literature. 59. Adapting to the 2018 Novel Foods Regulation: risk profiling the rearing 58. Acute reference dose setting for of house crickets, Acheta domesticus agrochemicals in Europe: a retrospective analysis SUPEANU Alexandru Directorate for Animal Health, National Sanitary STRUPP Christian Veterinary and Food Safety Authority in Romania, Gowan Crop Protection Ltd, Reading, United Kingdom Bucharest, Romania

Mary Moxon – RSA Associates, Inverkip, United Kingdom Xavier Fernandez-Cassi – Department of Biomedical Sciences and Veterinary Public Health, Swedish University Ivana Fegert – BASF SE, Ludwigshafen, Germany of Agricultural Sciences, Uppsala, Sweden Tina Mehta – DowAgrosciences, Milton Park, United Anna Jansson – Department of Anatomy, Physiology and Kingdom Biochemistry, Swedish University of Agricultural Sciences, Dana Sargent – Bayer AG, Monheim, Germany Uppsala, Sweden Maria Soufi – DuPont de Nemours Germany, Hamm, Sofia Boqvist – Department of Biomedical Sciences and Germany Veterinary Public Health, Swedish University of Agricultural Stephanie Zedet – Albaugh Europe Sarl, Lausanne, Sciences, Uppsala, Sweden Switzerland Merko Vaga – Department of Anatomy, Physiology and Phil Botham – Syngenta Ltd, Jealotts’s Hill, Berkshire UK Biochemistry, Swedish University of Agricultural Sciences Jean-Christophe Garcin – Bayer S.A.S, Sophia Antipolis, Michal Jan Czyz – Research Centre of Quarantine, Invasive France and Genetically Modified Organisms, Institute of Plant Richard Lewis – Syngenta Ltd, Jealotts’s Hill, Berkshire UK Protection – National Research Institute, Poznań, Poland Bennard van Ravenzwaay – BASF SE, Ludwigshafen, Ivar Vågsholm – Department of Biomedical Sciences and Germany Veterinary Public Health, Swedish University of Agricultural Sciences, Uppsala, Sweden The acute reference dose (ARfD) is designed to Novel foods represent a sustainable alternative to protect consumers from adverse effects following traditional farming and conventional food. Hence, acute (24 hour) oral exposure to pesticide residues. the interest for their scientific risk assessment as safe

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for human consumption. Starting 2018, Regulation danger to human health, and also do not change its (EU) 2015/2283 entered into force, regulating novel appearance, smell, taste and composition. foods in Europe. It lays down the requirements The European legislation on materials and articles enabling FBOs to bring innovative foods to the EU intended to come into contact with food includes market, while ensuring high levels of food safety harmonised rules in this area to protect consumers’ for European consumers. The risk profile assessed health and the removal of technical barriers to free the hazards for one of the most promising novel trade within the European Union. Manufacturers foods, Acheta domesticus crickets. The food model and retailers of food-contact materials and articles envisaged a closed-circle Acheta domesticus must comply with the requirements of traceability crickets rearing system, under HACCP and good as defined in the Framework Regulation (EC) No. farming practices, differentiating itself from outdoor 1935/2004. cricket farms. The methodology used involved scouting the literature and identifying possible The policy of the Republic of Bulgaria is hazards, followed by adding relevant inclusion synchronised with that of the European Union with criteria for the food model. These criteria engaged respect to food safety and is regulated by laws that animal health and food safety aspects, for the aim to establish the food requirements obligations entire lifespan of crickets, complying with the ‘from of producers, processors and traders of food and farm-to-fork’ One Health principle. When data were packaging. scarce, comparative evidence from close relatives The purpose of the present work is to draw trends of the Ortheoptera genus, like grasshoppers and from the data obtained from the official control locusts, was added. Significant data gaps in animal of materials and articles coming into contact with health and food safety were identified. Even if food in the territory of Bulgaria, such as bisphenol A, HACCP-type systems exist, the risk profile identified phthalates, etc. the following considerable risks: (1) high total aerobic bacterial counts; (2) survival of spore-forming Key words: food-contact materials, official control, Bulgaria bacteria post-thermal processing; (3) allergenicity of insects and insect-derived products; and (4) the bioaccumulation of heavy metals (e.g. cadmium). 61. Wines from Fruška Gora region of Serbia Other hazards like parasites, fungi, viruses, prions, – what about ochratoxin A? antimicrobial resistance and toxins were risk-ranked low to medium. For some hazards, an acute need TOROVIC Ljilja for additional research was identified (especially Faculty of Medicine University of Novi Sad chemical contaminants). To our knowledge, the present risk profile is the first assessing the rearing Diandra Pintać, Tatjana Majkić, Nataša Simin, Marija Lesjak, of Acheta domesticus as novel foods and presents Ivana Beara – Faculty of Sciences, University of Novi Sad an example for risk profiling other novel food insects. The region of Fruška Gora in the northern part of the Republic of Serbia is well known for its winemaking tradition, dating from the third century, 60. Summary results from Bulgaria when Roman emperor Probus planted the first for food-contact materials obtained vines and initiated viticulture in this region. The from the official control link between the diet and wine consumption is strengthened both by pleasure and the health TODOROVA Snezhana* benefits of wine, related mostly to cardiovascular Risk Assessment Centre on Food. Chain, MAFF and neurodegenerative diseases. However, wine is also recognised as one of the main contributors *Email: [email protected] to the dietary intake of ochratoxin A, widely known mycotoxin with carcinogenic, nephrotoxic, Food-contact materials are all materials and articles teratogenic and immunotoxic effects that could be intended to come into contact with food, such produced on grapes and transferred into wines. as packaging, containers, kitchen equipment, cutlery and dishes, bottles. Also included are those To evaluate the presence of ochratoxin A in wines used in processing equipment – coffee makers or from Fruška Gora, 91 bottled wines, produced in production machinery as well as containers used in 24 wineries over 2009–2015, were analysed using transport, materials that can reasonably be expected immunoaffinity columns for sample clean-up before to transfer their constituents to food such as a quantification of the toxin by high performance cardboard box around a plastic bag of cereals etc. liquid chromatography with fluorescence detection. The packaging that we use in our daily lives Quantifiable amounts of ochratoxin A (above 0.01 ng/ plays an important role in the quality of food as it ml) were found in 52% of the samples, and roughly provides food with permanent protection from their the same incidence was selected when samples surroundings, as well as from chemical and physical were grouped according to the colour of wine (red, contaminants. rose or white). Overall mean level of ochratoxin A was 0.021 ng/ml, namely 0.024, 0.028 and 0.017 ng/ In the production of food packaging and food- ml, in red, rose and white wines, respectively, without contact materials only materials and objects shall statistically significant difference between red and be used that are not released into food ingredients white wines. Maximum concentration of ochratoxin during storage and used in quantities that present a

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A (0.153 ng/ml) was found in a rose wine, however, it 63. Comparison of two methods for dietary was far below the allowed level of 2 ng/ml. exposure assessment to pesticide residues It could be concluded that levels of ochratoxin A in wines from the Fruška Gora region do not pose a risk WIDENFALK Anneli for human health, and this finding should promote National Food Agency their recognition and social popularity. Axel Mie – Karolinska Institutet, Sweden

To perform consumer intake assessments of 62. Cyanotoxin-rich irrigation water pesticide residues in food, EFSA and other causes extensive toxin bioaccumulation organisations use data on residue levels in food in spinach indicating considerable health and consumption data from dietary surveys. It is risk sometimes questioned if this method reflects the actual exposure, or if it over- or underestimates the intakes. In this project, the exposure of pesticide TSOUMALAKOU Evangelia residues was estimated using two different methods, University of Thesally firstly based on data on the mean residue levels T Papadimitriou, P Berillis, KA Kormas, E. Levizou in food from the Swedish monitoring programme in 2008–2012 and mean consumption data for 197 Cyanotoxin-rich irrigation water was applied by women aged 50–60 years from a dietary survey, spraying and root irrigation on spinach (Spinacia and secondly based on mean levels of metabolites oleracea L.) and the effect on growth and toxin of pesticides in urine from a group of 128 women loading in the edible tissues, subsequently health in the same age, converted to an estimated intake. risk, was investigated. The degraded water was The pesticides included in the study were 2,4-D, collected from the Karla Lake, Central Greece, chlormequate, mepiquate, chlorpyrifos and the which is characterised by eutrophic conditions groups dithiocarbamates and pyrethroids. None of and increased microcystin – an hepatotoxic the estimated intakes exceeded the respective ADI cyanotoxin – concentration. The plants were divided of the substances (0.01–18% of the ADI). It was shown into four groups, i.e. two of these receiving Karla’s that for chlormequat and the sum of pyrethroids, water to the root (KR) or by spraying (KS) and the the estimated intakes were similar. However, for corresponding controls receiving tap water (TR 2,4-D and dithiocarbamates the estimated intakes and TS). The experimental period lasted for three based on residue and consumption data were months, covering the whole growth period from the higher than when based on biomonitoring data, seed to the final harvest at marketable size. The MCs whereas the estimated intakes of mepiquat and were analysed with enzyme-linked immunosorbent chlorpyrifos were higher when based on levels of assay (ELISA) and detected on all the samples that metabolites in urine. Possible explanations for these received Karla’s water (roots, leaves and soil), while deviations are discussed. The study shows that no toxin were recorded to TR and TS. Significantly both methods can be used to estimate the intake high concentrations of bacteria attached on leaf of pesticide residues, but they both have strengths surface were measured by SEM in the two Karla and weaknesses. Based on the estimated intakes treatments, ranging from two to six times over among this subpopulation which has a relatively corresponding control plants. KS had more than high consumption of fruits and vegetables that 12.5 million bacteria per square centimetre of leaf contribute much to the exposure of pesticide residues, surface, while control plants hardly reached 3 million there is no concern for adverse health effects. bacteria. For toxin accumulation in edible tissues, KS leaves exhibited a significant toxin load, which was not considerably decreased after extensive 64. TKPlate: an open-source web platform washing of the leaves. Toxin bioaccumulation in KS for toxicokinetic models in food safety leaves showed a 66% increase compared with KR. In contrast, the KR roots absorbed more microcystins from the soil, so depleting its toxin content, while WIECEK Witold the KS roots accumulated less microcystins, leaving Analytica Laser the soil with a higher toxin content compared with Nadia Quignot, Billy Amzal – Analytica Laser KR. On human health risk, the estimated daily intake values of both leaves from Karla treatments Jean-Lou Dorne exceeded the tolerable daily intake limit (set by TKPlate is a web platform for running and working WHO) by a factor of 83 (KS) and 50 (KR). Our results with results of toxicokinetic (TK) models. Its defining indicate that irrigation of spinach with microcystins- feature is a ‘workflow model’, connecting any rich water constitutes a serious public health risk. number of generic models and data sources. This Subsequently, irrigation water quality monitoring software is written in R and is open-source, with the is considered indispensable and the relevant web interface programmed in Shiny. legislation urgent. Such workflow contains models or rules for dealing with available and missing inputs, e.g. performing in vitro extrapolation automatically if in vivo data are not available. Multiple models can then be linked

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together, e.g. TK-TD models or Dynamic Energy of RiskBenefit4EU concerns the development Budget (DEB) models. of a set of Risk–Benefit Assessment (RBA) tools to assess and integrate food risks and benefits Pre-sets and default values are available for all in the areas of microbiological, nutritional and parameters. Inputs are not ‘hard-coded’ in the chemical components through the development platform and can be stored in an up-to-date of a harmonised framework. This pilot project relational database. will validate the RBA framework created using a Monte Carlo method is used to propagate variability/ Portuguese case study on cereal-based foods. The uncertainty from all inputs through all linked models. research idea for food safety risk assessment is to Platform can work with a single mean (no variability) create an international network on RBA to promote or with multiple populations (e.g. poor and extensive and disseminate the outputs and knowledge metabolisers). Populations can be defined in terms acquired under RiskBenefir4EU, at European of customisable distributions on chosen parameters level. This network aims to promote knowledge (e.g. clearance) and pre-sets are available. and capacity building on RBA (acquired under RiskBenefit4EU) among European early stage An automated report is generated in Word or PDF, researchers and to apply the harmonised framework summarising the models applied, input values, TK on their countries. Health risks associated with parameters, generic plots. Full numerical outputs consumption of cereal-based foods, an important can also be exported. Experimental data can be source of nutrients with beneficial health effects, used for validation of the models and displayed could increase soon due to climate changes in alongside the outputs. Europe (dry conditions and increased ambient Currently, the models implemented in TK plate temperatures could promote an increase in toxins have been developed for humans and rats in the production; occurrence of emergent compounds) so context of exposure to single compounds and binary the dissemination and use of the RBA harmonised mixtures. These models are based on extension tools related with ingestion of cereal-based foods of functions and compound-specific data from and derivatives could contribute to support future the US-EPA ‘httk’ R package. Default mean and food and health policy in Europe. variability values for physiological and TK parameters are based on our meta-analyses of the literature. Performance of the current version of the tool has 66. Food risk–benefit assessment: been demonstrated in case studies modelling single ‘methodological development based compounds and binary mixtures. on an infant milk diet case study

Staying relevant in a changing world BOUÉ Géraldine Oniris INRA

Géraldine Boué, Sandrine Guillou, Jeanne-Marie Membré 65. Risk–benefit assessment in foods: a tool – SECALIM INRA Oniris Université Bretagne Loire 44307 Nantes France for a better food and health policy in Europe Enda Cummins – UCD School of Biosystems Engineering Dublin, Ireland ALVITO Paula Jean-Philippe Antignac, Bruno Le Bisec – Laboratoire National Institute of Health Dr Ricardo Jorge, Portugal d’Etude des Résidus et Contaminants dans les Aliments (LABERCA) INRA UMR 1329 LUNAM Université Oniris R Assunção, C Martins, S Viegas, P Fernandes, I Carvalho- Nantes F-44307 France Oliveira – National Institute of Health RJ, INSA, Porto & Centre for Environmental and Marine Studies (CESAM), Food risk–benefit assessment (RBA) aims to University of Aveiro, Aveiro, Portugal scientifically assess human health risks and benefits F Vasconcelos, P Nabais – Economic and Food Safety associated with food consumption in the same Authority, ASAE, Portugal integrative methodology, regardless of the field of D Torres, C Lopes – University of Porto, Faculty of Food research; including microbiology, chemistry and/ Sciences and Nutrition, Portugal or nutrition. Although these three components are M Poulsen, S Pires, L Jakobsen – Technical University of often present simultaneously on consumers plates Denmark, Denmark, DTU Food, Denmark and in their diets, up until the last decade they have B Géraldine, JM Membré – Institut National de la been traditionally studied independently. Since the Recherche Agronomique (INRA), France beginning of the 21st century, RBA has emerged Risk–benefit assessment in foods: a tool for a better food resulting from activities and development under and health policy in Europe EFSA guidance, European projects (Brafo, Qalibra, RiskBenefit4EU – Partnering to strengthen the Bepraribean…) and in particular RBA case studies. risk–benefit assessment within EU using a holistic The objective of the present work was to propose approach, is a recent European pilot project a method to perform a three-disciplinary RBA, funded by EFSA and coordinated by Portugal including microbiological, chemical and nutritional (PT), integrating a multidisciplinary team from dimensions. This work was performed as part of health and food institutes, national food safety a PhD project focusing on the infant milk-based authorities, R&D institutions and academia from PT, diet (breast milk and infant formulas), taking into Denmark (DK) and France (FR). The main objectives account a selection of risk or beneficial factors;

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namely Cronobacter sakazakii, Cryptosporidium, food safety (deposition of particles in plant tissues arsenic, dioxin-like polychlorinated biphenyls and and soil-forage-animal carry-over) docosahexaenoic acid. plant health (phytotoxicity) An updated RBA framework was then suggested, environmental impact (build-up in soil and adverse based on current trends and lessons learned from effects on soil organisms). the particular case study. In addition, four research questions were investigated: (i) how to carry out a Nanomaterials may pose hazards and risks that are multidisciplinary RBA considering microbiological, considerably different from conventional chemicals: chemical and nutritional aspects, is it possible to set the new conceptual framework of nano safety a generic framework? (ii) How to compare health assessment should support a robust scientific impacts, is it possible to use a common metric? approach to nano-fertilisers. Nano-fertilisers may (iii) How to consider variability and uncertainty in lead to considerable agricultural benefits (e.g. RBA? and (iv) How to communicate and interpret enhanced nutrient bioavailability), but also to RBA results? In the present communication, the potential risks. However, these issues are currently developed framework will be presented as well as not addressed in the Guidance on Nano Risk the main conclusions related to each question. Assessment under development. RBA currently appears to be an essential tool to provide comprehensive recommendations in terms of the food and human health nexus. It is 68. Environmental impact assessment also a complex and multidisciplinary approach of the food supply chain at various which has to face challenges from conventional geographical levels risk assessment but also challenges to aggregate, interpret and communicate all RBA results together GIBIN Davide to provide an overall health impact. EFSA

Anna Simonetto – Agrofood Laboratory, DMMT, UNIBS 67. Safety assessment of nano-fertilisers: Davide Arcella – EFSA time to take action? Gianni Gilioli — Agrofood Laboratory, DMMT, UNIBS Food production and processing have a high impact CUBADDA Francesco on the environment and there is much concern Istituto Superiore di Sanità, National Institute of Health about environmental pollution and demand for Federica Aureli, Alberto Mantovani – Istituto Superiore resources in intensive farming systems. Food-related di Sanità, National Institute of Health, Rome, Italy emissions account for 31% of the total greenhouse gas emissions of the European Union. This is Fertilisers are chemical compounds intended to expected to get worse as the world population is enrich agricultural soils and provide nutrients to constantly growing and it is estimated to reach plants. So-called EC fertilisers are regulated by around 9 billion people by the middle of this century, Regulation EC 2003/2003 on mineral fertilisers and with Europe increasing its population by around 4%. may circulate freely within the EU market. The rules In addition, a shift from a vegetable-based to a more for other fertilisers (national fertilisers) are currently meat-based diet has been observed, particularly in not harmonised at EU level and are governed by developing countries in the last years. national laws, although mutual recognition applies. The patterns of food consumption of the populations In March 2016 the Commission put forwards a are clearly the main driver of the food supply chain. legislative proposal on fertilising products, with This project is aimed at assessing the environmental two main objectives: (1) sustainable fertiliser footprint (carbon, water and ecological) of the food production from domestic sources, transforming consumed in the European Union at a different waste into nutrients for crops; and (2) harmonised level of resolution (region, country, EU), taking into cadmium limits for phosphate fertilisers. However, a account the food supply chain. Impact analysis consistent assessment framework on fertilisers is still focuses mainly on greenhouse gas emissions, water unavailable. Some EFSA opinions on contaminants consumption and land use. Data from the EFSA (e.g. nitrates, perchlorate) considered also the Comprehensive European Food Consumption presence in fertilisers. The DG SANTE Scientific Database are used for this assessment and statistical Committee on Health and Environmental Risks analyses are carried out to identify the role of (SCHER) has provided scientific advice on specific possible drivers (e.g. age, gender and country) of fertilisers issues (presence of cadmium, use of food consumption. A more in-depth analysis using a calcium cyanamide), but paid limited attention to the spatial scale model based on data from the Po Valley potential human exposure via the soil-food chain. (Italy) is presented for the livestock sector, which is responsible for 14.5% of total annual anthropogenic Nano-agrochemicals are an important application area of nanotechnologies in the agri-food sector with emissions world-wide’. nano-fertilisers featuring among the key innovative products. The extensive body of evidence on the fate and effects of nanoparticles in (edible) plants raises potential concerns in relation to:

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69. Risks and benefits associated with indirectly cause emerging risks. Climate change sharing of food is recognised as a critical driver and its impact on the occurrence and toxicity of toxin producing phytoplankton, bacteria and pathogenic viruses and LÜCKE Friedrich-Karl on other food safety domains was demonstrated. Fulda University of Applied Sciences With the aim of further exploring tools to identify and Rohtraud Pichner, Barbara Freytag-Leyer –Department of prioritise emerging risks, EFSA initiated a project focusing Nutritional, Food and Consumer Sciences, Fulda University on climate change as a driver of emerging risks for food of Applied Sciences, Leipziger Str. 123, 36037 Fulda, Germany and feed safety, including plant and animal health. A knowledge discussion group involving the Reduction in food losses is of high priority in making major institutions involved with climate change agro-food systems more sustainable. In Germany has been created. The group will define criteria to and other industrialised countries, losses in private identify relevant subdrivers (e.g. rising and more and institutional households account for a major fluctuating temperatures, changing precipitation part of total losses. There is rising concern among patterns, increase in natural disasters etc.), the issues consumers about these losses. Current information relevant to different food safety domains including and communication technologies facilitate the plant health and animal health, and to develop sharing of foods between private households, and a harmonised and transparent scoring system internet platforms such as ‘Foodsharing.de’ were applicable to the identified emerging issues to established. Moreover, ‘foodsharing fridges’ for prioritise future research and risk assessment activities. use by consumers to deposit and withdraw food have been set up in some (mainly urban) locations. Based mainly on experiences from Germany, we analysed the risks and benefits associated with food 71. SEAFOODTOMORROW: nutritious, safe sharing. We found the initiatives to reduce food and sustainable seafood for consumers losses by sharing food to be a useful tool in raising of tomorrow the appreciation of food and promoting knowledge and skills related to food handling and food storage. MARQUES António Conversely, certain hazards that are not noticed Portuguese Institute of Sea and Atmosphere through spoilage symptoms may be introduced by the donator of foods, as a consequence of possible poor handling and storage. In particular, food Introduction: SEAFOODTOMORROW is an H2020 sharing fridges must be operated in a responsible European-funded innovation action led by IPMA manner, as the responsible individuals may be that started on the 1 November 2017 and will end considered as ‘food business operators’ in the legal on 31 October 2020. This project’s large consortium sense, and traceability of the food becomes an is composed of institutions from 15 European issue. However, we found it possible to set up and countries, with 19 interdisciplinary research teams, implement simple, plausible rules for users of food four Interest Association Groups and 13 Small and sharing platforms and fridges. We also propose an Medium Enterprise. approach to be taken by food inspectors in assessing Objectives: The project aims to optimise and validate the safety of operation of food sharing fridges in a eco-innovative sustainable solutions to improve the risk-based way. So, a sound compromise appears to socioeconomic and environmental sustainability be feasible to maintain the benefits of food sharing of seafood production and processing sectors, systems while keeping food safety risks at a minimum. while preserving seafood quality and safety and promoting seafood consumption in a healthy diet. Methodology: SEAFOODTOMORROW activities 70. Climate change and emerging risks include, among others: (a) utilisation of sustainable for food safety agro-food byproducts to develop more sustainable and adequate feeds for aquaculture; (b) design of MAGGIORE Angelo seafood products targeted to different population EFSA segments (elderly, pregnant women and youth); (c) reduction of salt (sodium) in processed seafood; Ana Afonso, Giacomo de Sanctis, Didier Verloo, Ciro Gardi, (d) validation of strategies to reduce contaminant Sophie Dhollander, Yves Van der Stede, Marco Binaglia, levels in seafood; (e) optimisation of sensors Jose Tarazona and biosensors as rapid screening tools for the According to the General Food Law, the European assessment of seafood safety; (f) validation of Food Safety Authority (EFSA) is required to identify environmentally sustainable and more effective emerging risks in the fields within its mission. seafood processing methodologies; g) optimisation EFSA has developed a methodological framework of seafood production in multitrophic aquaculture; for identification of emerging risk, starting from a (h) implementation of digital traceability systems preliminary identification of priority emerging issues with labelling systems that provide consumers through knowledge networking activities. The long- and the food industry with real-time information term anticipation of emerging risks includes the about products quality; (i) improvement of an online identification of drivers. Drivers are the underlying information tool for consumers that balances the natural or human-induced factors that directly or benefits and risks associated with their seafood

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intake; and (j) establish a baseline for seafood quality for this promising approach supporting a science- certification schemes in Europe. based decision process in the area of risk–benefit management of foods. This project is organised in five innovation Work Packages (WPs), each addressing specific objectives and three WPs focused on communication, dissemination and exploitation, management and 73. Is EFSA addressing environmental risk coordination and ethics. related to food production? To secure a successful outcome and achieve the highest return of public investment, the RIOLO Francesca SEAFOODTOMORROW consortium covers a wide Independent researcher geographic area across Europe, including the most relevant seafood producers, processors and Christoph Eugen – Independent researcher countries consuming seafood products. A case is here made on the role that the General Website address: http://www.seafoodtomorrow.eu/ Food Law (GFL) legal framework and EFSA could play in addressing the risk related to the impact that food production is causing on the environment including biodiversity loss, habitat degradation and 72. Risk–benefit assessment of foods: key destruction, climate change, ecosystem services findings from an international workshop disruption, pollution and waste of resources. The recent REFIT (EC 2015) audit of the GFL found PIRES Sara that “although no systemic failure was detected, Technical University of Denmark the General Food Law might be inadequate to Géraldine Boué – INRA address food sustainability...”. Currently no action on Hanna Eneroth – SLV this fundamental aspect is included in the EC new proposal for amendment of the GFL launched in 2018. Alan Boobis – Imperial College London The author propose that the GFL and EFSA could Jeanne-Marie Membré – INRA take a wider responsibility over food sustainability by Juliana Ruzante – RTI fully acknowledging the scientific evidence on the Jakob Van Klaveren – RIVM environmental impacts of the current food production Morten Poulsen – DTU Food system and consumption patterns, and applying an Nauta Maarten – DTU Food ecosystem-based approach to environmental risk assessment. The GFL framework could recognise While protection of public health and the the fundamental transformation that needs to be environment from untoward risks is a key goal of applied to the food production system to achieve regulation, risk management options, including food sustainability while EFSA could take a leading role in policy ones, may be associated with a corresponding assessing and communicating all the risks related reduction in benefit, direct or indirect. Policy to industrial agriculture practices, run holistic cost/ decisions require consideration of the necessary benefits analysis, establish appropriated targets trade-offs, and hence there is an increasing need to and indicators, identify and communicate available apply formal risk–benefit assessment (RBA) of foods. alternatives, and provide independent information In this context, the European Food Safety Authority and advice to be passed on to farmers, consumers, sponsored a Risk–Benefit Assessment Workshop food industry representatives, retailers and all on ‘past, current and future developments within stakeholders involved in the food chain. This work the risk–benefit assessment of foods (RBA)’ held would be in line with the mentioned international in May 2017. The overall aims of the RBA Workshop and European efforts towards environmental were to discuss existing methods, challenges and sustainability. It would also support the objectives needs within RBA, and to draft a roadmap for of the Directive on Sustainable Use of Pesticides future development of RBA. The specific objectives that, despite its good intentions, seems ineffective were to: (i) identify RBA activities in Europe and so far, while pesticides sales in the EU have even globally; (ii) discuss how to further develop and increased since its adoption. Viable alternatives to optimise RBA methodology; (iii) identify challenges intensive industrial agriculture based on the ecology and opportunities within RBA; and (iv) increase of diversified agricultural systems and natural collaboration internationally. The two-day workshop ecosystem services and, where appropriate, mutual gathered 28 participants from 16 institutions in 11 funds, are available and should be better supported countries. It included technical presentations of and developed through measures that could allow RBA methods and case studies, and two break- the shift from an unsustainable industrial agriculture out sessions for group discussions. All participants infrastructure and paradigm to sustainable agreed that RBA has substantial potential to inform agroecology. The next EFSA Strategy could be risk management decisions in the areas of food drafted on the basis of a vision on what needs to safety, nutrition and public health. Several activities be done to achieve a desirable and sustainable to optimise further developments within RBA were future built around food sustainability, to continue suggested. We present a summary of workshop ensuring safe food to EU citizens and in support of presentations, a discussion of challenges that limit international and European efforts such as the UN progress in this area, and suggestions of next steps Sustainable Development Goals, the EU Biodiversity

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Strategy and the 7th Environment Action Program. emerging countries, are increasingly seeking foods According to the strategic objective “Create an that are grown locally with minimal ingredients environment and culture that reflects EFSA’s or those that contain only natural constituents. values”, EFSA could actively engage into raising Others are seeking exploring alternatives to awareness among staff and experts over the impacts traditional foods, such as plant-based meat and that current food production and consumption convenience in how food is delivered. While this patterns, and related individual choices, have on the disruptive landscape has numerous benefits, environment, and use food sustainability guidelines it can also present challenges in food safety for as a code of cinduct when organizing events and both chemical and biological hazards. Here we outsourcing catering services. Evolving towards the explore how these trend shifts pose a dilemma establishment of a European Food Sustainability challenge for toxicologists and microbiologists that Authority and challenging the current major crisis, are tasked with risk assessment, management not only on the basis of societal expectations and and communication. In particular, we examine a values, but on the solid and extensive available separate approach to assessment. In the United scientific evidence, is what could be truly called States (USA), the risks posted by chemicals in the “contextualising risk assessment”, “advancing risk diet and pathogens in food are typically assessed assessment science” and “staying relevant in a separately. This divide is further exacerbated by changing world”, the themes of this year conference. unaligned training and workshops that focus on either chemical safety, such as pesticide applicator training, or prevention of biological hazards, such 74. Protecting the EU plant health: as USDA GAP, GlobalGAP and produce grower training. The recent Food Safety Modernisation assessing the risk of plant pests under Act (FSMA) provides an opportunity to harmonise global change these fields through better integration of biological and chemical hazard prevention and mitigation STANCANELLI Giuseppe approaches. While FSMA is a good platform to EFSA coordinate efforts from a regulatory perspective, it is insufficient to maintain relevancy in a fast- Giuseppe Stancanelli, Denise Candiani, Ramona M. moving society. As entrepreneurs and companies Ciubotaru, Ewelina Czwienczek, Alice Delbianco, Franco continue to innovate, it is critical that food safety Ferilli, Ciro Gardi, Tomasz Kaluski, Virag Kertesz, Svetla Kozelska, Maria Rosaria Mannino, Olaf Mosbach-Schulz, scientists engage with stakeholders across Joshua Oyedele, Emanuela Tacci, Sara Tramontini, Sybren agricultural, commercial and public sectors. This Vos, Gabriele Zancanaro – EFSA Animal and Plant Health Unit includes industry food scientists, marketers, culinary professionals, nutritionists, packaging engineers, With global change the risk of biological invasions of consumer groups and many others who are at the new exotic plant pests into Europe has dramatically forefront of food development. Working towards increased, threatening agriculture production, integration will improve our ability This diverse forestry, biodiversity and the environment. EFSA group will help to guide scientists to prioritise activities in plant health risk assessment include hazards, estimate exposure, identify data gaps and continuous support for the new EU plant health manage risks posed by changing dietary trends. law (pest categorisation, pest risk assessment, commodity risk assessment and impact assessment for prioritisation of risk mitigation measures) as well as crisis preparedness, such as horizon scanning 76. EFSA’s Emerging Risk Identification for identification of new plant health threats process and the development of risk-based surveillance guidelines. For new plant pests, scientific advice to YIN Anran risk managers is provided on risk and risk mitigation EFSA measures, whereas the analysis of uncertainties helps to identify key knowledge gaps and research Anran Yin, Caroline Merten, Raquel Garcia Matas, priorities. The principal flows of activities of EFSA in Tilemachos Goumperis, Agnes Rortais, Angelo Maggiore, Ana Afonso, Tobin Robinson, Georges Kass – Unit on plant health are presented, including the interactions Scientific Committee and Emerging Risk Unit (SCER), Risk with risk managers, researchers and stakeholders. Assessment and Scientific Assistance Department (EFSA)

According to the European Food Safety Authority’s 75. Opportunities to integrate biological and (EFSA) Founding Regulation EFSA is required to chemical hazard prevention in a disruptive establish procedures for the screening and analysis food landscape of information with a view of identifying emerging risks in the fields within its mission. STONE David Identification of emerging risks prepares for future Oregon State University risk assessment needs on new food supply chains and technological developments. The definition Jovana Kovacevic – Oregon State University of an emerging risk encompasses the context of Across the world, the way in which food is grown, novelty, a new hazard or a known hazards emerging transported and consumed is rapidly changing. in new conditions. The challenges for identification Many consumers, particularly from developed and arise from the uncertainty, lack of data and the

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difficulty to quantify the risk. The European Food The strategy to execute the objective will be Safety Authority has developed a process for performed through the insertion of specific designed the identification of emerging risks in food and training programmes at different docent levels: feed that relies on networks of knowledge with bachelor degrees, masters and doctorate. Moreover, multidisciplinary expertise. a search will be performed to find other international universities or research institutes engaged with Between 2010 and 2017 the Emerging Risks similar objectives. It is also essential to identify the Exchange Network (EREN) (collaboration with right competence and skills to be acquired related Member States) and the Stakeholder Discussion to the specific formation plans: e.g. Specific food Group on Emerging Risk (StaDG-ER) (collaboration regulations, database collection management, with civil society and private sector) assessed more omics and bioinformatic tools and negotiation and than 120 potential emerging issues. The issues communication skills. The programme should be discussed were mainly microbiological and chemical presented to the suitable University entities to be hazards, but also food safety issues such as those approved. A pilot plan will be presented at the faculty resulting from unlawful activity, new consumption of Pharmacy, Human Nutrition and Food Science at trends, biotoxins, new technologies and processes, the University of Granada. allergens, animal health, environmental pollution, new analytical methods, new food packaging technology and unknown hazards. Based on the available evidence, the networks recommended 78. The Italian cooperation with EFSA: whether an issue merited follow-up actions, such as strategies and actions generation of new data, a full risk assessment and/or consultation with other bodies. BUSANI Luca Further efforts are needed to create a common Istituto Superiore di Sanità mechanism to share experiences across Europe on Maria Girolama Falcone, Alessandra Perrella, Simonetta the different methodologies applied, as well as to Bonati, Daniela Rodorigo – Ministero della Salute, Direzione pool the intelligence gathered. EFSA has initiated generale degli Organi collegiali per la tutela della salute the development of a data management system Camilla Marchiafava – Istituto Superior di Sanità to facilitate access, review and analysis of identified issues and a collaboration system for knowledge Working together and exchanging knowledge sharing between networks of expertise. between food safety experts ensures excellence and efficiency and maximises Europe’s risk assessment capacity and potential is the European Food Safety Envisioning the expertise of the future Authority (EFSA) strategy and the commitment of the Italian Food Safety Authority, the Direzione Generale degli Organi Collegiali per la Tutela della Salute (DGOCTS) of the Ministry of Health. 77. Strategic programme for promoting university engagement with food risk The DGOCTS and National EFSA Focal Point in 2013 assessment science developed a strategy for the improvement of the national risk assessment capacity, mainly through the promotion of the cooperation with EFSA. The AGUILERA Margarita target was the national competent organisations University of Granada, Spain network (Article 36 organisations). From 2013, the Ana Rivas, Francisco Arrebola, Alba Martínez-Burgos – quality and the number of competent organisations University of Granada, Spain increased constantly. These achievements were also reflected in the increase of the number and Risk assessment science should be built from success rate of the applications to EFSA calls. In integrative approaches that should be synergic addition, two Italian researchers and one national and convergent to face complex global food safety competent organisation are involved in the EU- issues. Nowadays, one essential task is to transfer FORA programme. to the civil society the relevance of risk assessment The actions were implemented according to two science, especially in food and feed and its impact principles: assessment of the capacities of the in health and nutrition. It is mandatory to put in competent organisations and promotion of the value the work already performed over decades, national and EFSA cooperation strategy. problems faced, achievements and future needs and challenges. A formal assessment process of the organisations was established, to ensure the accomplishment The Universities have a strategic position to send of the criteria according to the EU regulations an impacting message with a wide scope within and the scientific and technical capacities of the the students that will become a key part of the organisations. future society. The main objective is to draft a complementary formative plan for potential future A communication-based programme of workshops food risk assessors, regulatory scientist and other and trainings was developed and delivered in figures that could facilitate fruitful and successful several rounds in different places, involving all communication and discussions with e.g. policy the competent organisations and also research makers, industry and healthcare systems. institutes outside the Article 36 network, to promote

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contacts and networking. Moreover, a regular 80. Next Generation Chef: foods 4 sharing contact by email and telephone with the researchers of the competent organisations was maintained, GOVONI Luca to ensure a constant update of the organisation ALMA – La Scuola internazionale di Cucina Italiana profile, and to inform them about cooperation opportunities, national initiatives and trainings. Andrea Sinigaglia, Davide Mondin, Fabio Amadei – ALMA

This national strategy, allows the DGOCTS to The Next Generation Chef survey (2015) and the maintain operational a network of excellence lesson ‘Perspectives in food sustainability’ (2016) institutions that are competent in risk assessments have enabled us to draw up an additional document for the national authority. – called MAGNA CARTA (published in 2017) – that let people believe, observe, be aware and work to enhance world’s resources and it ensure that new 79. Risk Assessment Methodologies cooks, pastry chefs and professionals are the main Programme (RAM-Pro) people to save our planet and its biodiversity. Article 1, generate culture; Article 2, right to choose their own food; Article 3, right to healthy food availability; ERYASA Berrak Article 4, right to information and education; Article EFSA 5, food safety assurance; Article 6, safeguarding the territory; Article 7, sense of responsibility; Article 8, Background: EFSA has set its strategic objectives company’s progress; Article 9, correct information; to drive efforts for the next five years (2016–2020) to Article 10, the role of cooking schools. steer the organisation to the future in its Strategy 2020 plan. Specifically, the strategic objective 4 The new goal of the project Next Generation Chef (SO4) is about EFSA being prepared for future wants to improve the dialogue between them and risk assessment challenges. In this five-year the scientific community to satisfy one of people’s implementation plan, a large number of EFSA’s primary needs: safe and good food. In this way, we scientific development projects was identified and want to create a network to revolutionise the way included in the Risk Assessment Methodologies of teaching in the culinary field, motivate students Programme (RAM-Pro) to achieve EFSA’s strategy in and professionals to collaborate with each other in relation to development of new RA methodologies the promotion of the value of food. The goal is to and their harmonised use. create an international platform for cooking schools, where professionals can meet and discuss food Objective: to identify, coordinate and monitor all preparations and provide their views about it. projects dealing with risk assessment cross-cutting 81. methodologies development, and aligned to ensure EFSA is prepared for present and future challenges in a dynamic food safety system. 82. Leveraging scientific cooperation Method(s): RAM-Pro coordinates 40 EFSA scientific with EFSA: a pilot pesticide dietary projects dealing with cross-cutting RA methodologies exposure assessment in Chile in three thematic areas: Chemicals RA for human health, Environmental RA with a focus on chemicals ORTUZAR Juan and Harmonisation of RA methodologies. Continuous ACHIPIA cooperation and facilitating communication among projects, mainly by three multiproject Eduardo Aylwin, Constanza Miranda, Gustavo Sotomayor, Steering Committee meetings (mPSC) separately Juan Ortuzar, Nuri Gras – ACHIPIA for each cluster allow project managers to exchange information on their ongoing projects. Introduction: Chile has two pesticides surveillance programmes, one under the Ministry of Health and Expected Results: RAM-Pro plays a major another under the Ministry of Agriculture. Both have role in identifying and prioritising projects, by been working for almost 10 years collecting valuable fostering a collective approach, cooperation data for analysis. Nonetheless, insufficient scientific- and communication between EFSA Units. The based evaluation of the results has been made. So, programme helps to identify, at an early stage, the Chilean Food Safety Agency (ACHIPIA) engaged gaps and synergies between projects together into a collaboration with EFSA to strengthen the with expected benefits, risks and lessons learned. skills to run critical analysis of the current pesticide In addition, the main outcome of RAM-Pro is surveillance programmes. The main objectives of promoting accessibility and the use of EFSA this collaboration were to develop: (1) an integrated methods/tools inside and outside, endorsing trust in pesticide surveillance programme; and (2) a dietary EFSA’s work and stakeholder satisfaction. exposure assessment using the data from the current programmes. Here we present the main Conclusion: All projects in the RAM-Pro contributing findings of the dietary exposure assessment. to the development of cross-cutting methodologies in risk assessment are coordinated in an efficient Material and methods: For the dietary exposure manner that allows harmonisation of the best assessment, results of the surveillance programme practices to keep EFSA up to date in facing from the Ministry of Agriculture of 2016 were used, challenges in European food safety. with 1,956 samples and 180 analytes. The tool used

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to conduct this assessment was EFSA PRIMo. Most students. These encouraging results represent only of the working principles, concepts and tools used half of a win, due to the few opportunities to land were learned through the collaboration agreement a job in One Health. In other words, we are training between EFSA and ACHIPIA signed in 2017. One Health minds that will not be used in practice. Results, discussion and steps forwards: Chronic exposure This concept paper represents, from our knowledge, assessment indicates that only methamidophos is over the first one to reveal the situation of the future of 100% of the ADI. Only eight pesticides were in the range One Health: its students! of 11–100% ADI, 43 in the range of 1–10% ADI and 30 below 1% ADI. From an acute exposure perspective, none of the data exceeded 100% ARfD. All these results correspond Environment to local consumption produce and fruits data indicate no problems. These results provide strong science- based evidence to local surveillance programmes and risk management decisions. Additionally, it shows how 84. Evaluation of marking methods fruitful can be these technical collaborations between in farmed salmonids for tracing purposes agencies, to further implement skills and tools learned, – impact on fish welfare such as the Standard Sample Description and PRIMo to improve local capacities, surveillance programmes, MRL BASIC Dean setting process, among others. VKM staff, Norwegian Scientific Committee for Food and Environment

83. One Health in science and society. Stein Mortensen – VKM member, Institute of Marine Research A glimpse into the future: its students! Angelika Agdestein – VKM staff Tore Kristiansen – External expert, Institute of Marine Research Cecilie Mejdell – VKM member, Norwegian Veterinary Institute SUPEANU Teodora-Diana Department of Infectious Diseases and Preventive Medicine, Ingebrigt Uglem –External expert, Norwegian Institute for Nature Research Faculty of Veterinary Medicine in Bucharest, Romania

Emily Hardgrove, Anastasia Lambrou, Pallavi Oruganti, Neil Escaped farmed Atlantic salmon (Salmo salar) is Vezeau – Students for One Health, United States of America considered a threat to wild salmon. The Norwegian Arinjay Banerjee – Students for One Health, Canada authorities are aiming at preventing escapes from occurring and remove escapees from the Alexandru Supeanu – Students for One Health, Romania environment, following the ‘polluter pays’ principle. As One Health builds up momentum in our society, To take action to reduce the impact of escapees, construction on an international system of values, methods to distinguish escapees from wild fish and goals and connections based on this concept has to trace them back to their origin are in demand. already started. Human and veterinary medicine, The Norwegian Scientific Committee for Food and the environment, biology, social sciences, art, Environment (VKM) assessed the risks of reduced mathematical sciences, IT, risk assessment and welfare for farmed salmonid fish, associated with the management, all are under the One Health different marking and tracing methods. A variety umbrella and have a shared mission. We are of marking methods such as fin clipping, freeze building pioneer bridges between academia, branding, different external and internal tags, as well NGOs, institutions, industry and consumers. But as natural and chemical marks, were considered. what are we doing to pass on all of this to the Visible marks may be combined with either tracing future One Health generation? Is the current One of natural marks or the use of coded wire tags or Health framework providing them with sufficient passive integrated transponder tags, which have resources? Will it be sustainable? a sufficient number of available codes, enabling identification of the fish on an individual – or batch The scope of the present work, started in 2017 and level. Natural or chemical marks were assessed still ongoing, is to identify, at an international level, as having the lowest risk on reduced fish welfare, One Health resources available, in all aspects, to although analysis of marks may require killing the students. The inclusion criteria were education and fish after a catch. By contrast, spraying of pigments work opportunities, alongside other benefits that and most externally attached tags represents a high can be monetised by students in pursuit of a One risk of reduced welfare, both on short-term and Health career. long-term perspectives. The overall conclusion by We have identified over 60 active One Health VKM is that no combinations of marking and tracing student hubs world-wide, from One Health methods exist that are feasible without an increased university clubs, autonomous groups to international risk of reduced animal welfare. Data gaps related to aggregator movements, as Students for One Health. the impact of marks on fish welfare were identified. We also highlight 70 academic and non-academic These include the functional role of the adipose fin, educational opportunities (from bachelor to post- making assessment difficult about how fin clipping doc level). Moreover, online data indicates that over affects the fish on a long-term basis. Regardless of 5,000 students are connected to the One Health the method used to tag fish, large-scale marking will information sharing networks. Almost 25% of online always represent higher risks of human errors and visits to One Health specific sites are performed by reduced fish welfare as opposed to small-scale marking.

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85. ECPA proposal for an expert judgement Human Health (HHRA) and Environmental Risk based approach to Specific Protection Assessment (ERA) of combined exposure to multiple Goals (SPGs) for EFSA Non-Target Terrestrial chemicals raised concerns among scientists, risk assessors and risk managers, particularly due to the Plants, Non-Target Arthropods and Soil complexity of the problem formulation, the huge Organisms Guidance Documents based on number of chemicals involved, the toxicological the EFSA Ecosystem Services Approach profiles and different routes of exposure of these chemicals. From a risk assessment perspective, it is CAMPBELL Peter practically impossible to test all possible mixtures Syngenta experimentally, therefore it is needed to find smart strategies to assess the potential hazards using new European Crop Protection Association tools that rely less on in vivo testing and incorporate instead alternative experimental and computational Currently there are three Scientific Opinions tools. The European Food Safety Authority (EFSA) from EFSA that are waiting to be developed into has identified as a key priority the development of Guidance Documents i.e. Effects of Pesticides harmonised methodologies for HHRA and ERA of on Non-Target Terrestrial Plants, Soil Organisms combined exposure to multiple chemicals, initiating and Non-Target Arthropods. While each of these ‘MixTox’ Working Group. In 2017, EFSA published Scientific Opinions makes proposals for SPGs, an External Scientific Report summarising the the European Commission and Member States development of innovative in silico QSAR models as should agree on the SPGs before they can be taken tools to predict toxicity values or classify thresholds forwards to be used in the Guidance document of single chemicals for HRA and ERA by using EFSA’s development phase. The purpose of this paper is OpenFoodTox database. to provide input for consideration and discussion during this process. Our research project aims at applying and further developing current QSAR models (e.g. CORAL) The predicted impact of any effect of a plant for hazard characterisation of binary mixtures protection product (PPP) on an invertebrate/plant in species of human health (rats, mice) and of population should be described using expert ecological relevance (bees, Daphnia). Mathematical judgement, which combines the predictions models such as Concentration Addition (CA) and using the following EFSA 2010 dimensions (i.e. Independent Action (IA) as well as the Toxic Unit attribute/nature of effect, magnitude, temporal (TU) approach will be applied and tested within and spatial scales of effects) as well as the number different case studies. QSAR modelling will be and importance (e.g. keystone species) of species based on the sum of toxic units (sTU) derived potentially affected,. This expert judgement must from single chemical; this will provide a basic risk be carried out within the context of the intended characterisation for the compound of concern in the field conditions of use of the PPP and should also mixture. QSARs models will applied to (a) predict take into account any proposed risk management (missing) information on individual compounds; (b) measures. An additional element that should be predict directly or stepwise the combined effects taken into consideration when setting SPGs, which and interactions of chemicals in the mixture; and was not listed in the EFSA SPG Opinion (EFSA 2010; (c) assess whether chemicals will act in a similar or EFSA 2016) is the frequency of occurrence of an dissimilar way to perform their grouping. Overall, impact. For example a 1 in 20 year event should be this project will allow EFSA’s Working Group ‘MixTox’ of much less concern that an impact that occurred to develop its Guidance document aimed at after every application. Then using this described harmonising the current methodologies for HHRA expert prediction of the impact of the PPP, an and ERA of multiple chemicals due in 2019. informed choice can be made by all stakeholders as to the acceptability or otherwise of the effects being predicted in the risk assessment. 87. Traceability of cooper along of soil- plant-bee products chain 86. Development of innovative open-source QSAR models for human and ecological CIORNEA Laura-Ancuta risk assessment of emerging contaminants Sanitary Veterinary and Food Safety Directorate Liliana Crisan, Dorina Lazin – Sanitary Veterinary and Food and their mixtures Safety Directorate, 66 Vasile Alecsandri Str., Baia Mare, Romania CARNESECCHI Edoardo Liviu Giurgiulescu – Technical University of Cluj-Napoca, Institute of Pharmacological Research ‘Mario Negri’ North University Centre of Baia Mare, Chemistry and Biology Department, 76A Victoriei Str., 430122, Baia Mare, Romania Emilio Benfenati – Institute of Pharmacological Research ‘Mario Negri’ The study presents the influence of the soil’s Jean-Lou Dorne – EFSA pollution with heavy metals influences the mineral content of honey bees and implicitly the honey Humans and ecosystems are continually exposed quality. The study was performed in situ by location to very complex mixtures of chemicals, the the bee hive in two areas: non-polluted area (as composition of which is continuously changing. reference area) and a strongly polluted area with

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heavy metals. Samples of soil, mellifera plants, bees Hermann Broll, Yann Devos – EFSA, GMO Unit, Parma, Italy and bee products were collected from both areas Thomas Frenzel – Landesuntersuchungsanstalt für das and analysed using AAS method to establish the Gesundheits und Veterinärwesen Sachsen, Dresden, Germany total and leachable content of cooper. The positive Antoine Messéan – INRA, Unité Eco-Innov, Thiveral- relationship regarding the copper traceability Grignon, France was validated along the soil–melliferous flora– Franco M Neri – EFSA, GMO Unit, Parma, Italy honeybees–honey and propolis chain. Honeybees Joe N Perry – Oaklands Barn, Norfolk, UK can be treated as ‘bio-indicators’ for copper pollution Fabio Veronesi – Università degli Studi di Perugia, Italy within their environment. Andrea Gennaro – EFSA, GMO Unit, Parma, Italy

The agronomic/phenotypic and compositional 88. EFSA develops scientifically based characterisation of genetically modified (GM) plant pest survey guidelines for EU plants is an important pillar for the risk assessment Member States of GM plants and derived food/feed products. Compositional and agronomic/phenotypic data are determined to identify similarities CIUBOTARU Ramona and differences between the GM plant and its European Food Safety Authority conventional counterpart. Agronomic/phenotypic and compositional data should be gathered from José Cortiñas Abrahantes, Joshua Oyedele, Stephen Parnell, Gritta Schrader, Gabriele Zancanaro, Sybren Vos plants grown under environmental and agronomic conditions which are representative of possible The European Commission requested EFSA to receiving environments in which the GM plants can facilitate the Member States (MS) in the planning be grown (EFSA GMO Panel, 2015). and execution of their survey activities. In particular, Here, we present an approach based on climatic and EFSA is asked to provide scientific and technical land suitability classes reported by Sys et al. (1993) guidelines in the context of the new plant health to appraise the representativeness of field trial sites regime (Regulation (EU) 2016/2031), which gives an in a transparent and repeatable way. Crop-specific extra focus to prevention and risk assessments. requirements corresponding to different conditions In this context, 47 pest survey cards are being developed for cultivation (ranging from optimal to non- for pests of EU relevance (Regulation (EU) No. 652/2014) suitable) are used graphically to show the specific within the European Commission co-financing characteristics of the field trials against the different programme of the annual MS survey activities. classes identified. Similarly, additional analyses are integrated to evaluate the representativeness Each survey pest card summarises the biological of the farm management practices applied in and epidemiological key information relevant for the selected field trials. This approach enables the detection and identification of the pests by you to: (1) facilitate the selection of representative inspectors and laboratory technicians in the MSs. sites based on historical meteorological data, soil Moreover, guidelines for three pilot pests are being characteristics and site distribution against maturity prepared for the survey planners and designers in groups of the test materials (a priori); (2) assess the the MSs, providing them with: representativeness of selected sites taking into (i) support on the underpinning statistical methods, account the specific conditions of the year/s of the and use of the EFSA WEB-based tools RiBESS+ and field trials (e.g. agro-meteorological conditions SAMPELATOR to inform sampling strategy design, and crop management practices) (a posteriori). including sample size calculations; This approach is now routinely applied by EFSA to appraise the representativeness of field trial sites (ii) the relevant practical information for the submitted as part of the data package for the implementation of surveys. authorisation of GM plants for food/feed uses, import In the development of these deliverables, and processing in the EU. interaction with the MSs is needed before and after References implementation of the pilot guidelines for ensuring Sys et al. 1993. Land evaluation, Part III crop requirements, there are fit for purpose and harmonisable across the EU. Agricultural Publication No. 7. EFSA GMO Panel 2015. EFSA Journal 2015;13(6):4128, 44 pp.

89. Appraising the representativeness of field trial sites for the agronomic/ 90. A global database of the host plants phenotypic and compositional of Xylella spp. characterisation of transgenic plants DELBIANCO Alice DE SANCTIS Giacomo European Food Safety Authority (EFSA), European Food Safety Authority (EFSA), GMO Unit, Parma, [email protected] Italy Alice Delbianco, Andrea Baù, Tomasz Kaluski, Svetla Fernando Alvarez – EFSA, GMO Unit, Parma, Italy Kozelska, Olaf Mosbach-Schulz, Irene Muñoz Guajardo, Marco Pautasso, Giuseppe Stancanelli, Sara Tramontini, Paolo Bàrberi – Institute of Life Sciences, Scuola Superiore Ewelina Czwienczek – EFSA, Via Carlo Magno 1A, 43126 Sant’Anna, Pisa, Italy

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Parma, Italy declining. Reliable monitoring methods are essential for tracking the status of ecosystem Xylella fastidiosa was first detected under field services. Predation is the mainstay of natural pest conditions in Lecce province in Apulia (Italy) in control, a key ecosystem service. We used green October 2013, where the outbreak was mainly plasticine caterpillars to monitor predation pressure, characterised by extensive leaf scorch and dieback and to obtain baseline data on predator activity in olive trees. Since then, X. fastidiosa has been in transgenic Bt versus non-Bt maize. Predation reported outdoors in many different plant species pressure was measured at ground and canopy levels also in Corsica, South France (Provence-Alpes Côte using an identical, small-plot experimental design d‘Azur), the Balearic Islands and mainland Spain in four European countries (Denmark, Slovakia, (Alicante). Romania and Italy) and Argentina. Total predation The European Food Safety Authority (EFSA) rate in maize was 11.7% day−1 (min. 7.2% day−1 in produced urgent advice and a pest risk assessment Argentina, max. 29.0% d−1 in Romania). Artificial together with the evaluation of risk reduction caterpillars were attacked both by invertebrates options (EFSA, 2015) to scientifically support the (mostly chewing insects with 42.0% of the attack EU risk managers in the identification of measures marks, and ants with 7.1%, but also predatory to prevent further introduction and spread of this and parasitoid wasps, spiders and slugs), and quarantine pathogen. vertebrates (small mammals 25.5%, and birds 20.2%). Total predation at ground level (15.7% day−1) was Moreover, EFSA has developed and maintained a significantly higher than in maize canopies (6.0% database of the reported host plants of Xylella spp. day−1) in all countries, except Argentina. We found no A list of Xylella spp. host plant species derived from significant differences between predator pressure in an extensive literature search up to November 2015 Bt versus non-Bt maize plots. The artificial caterpillar included 359 plant species from 204 genera in 75 method provided comparable, quantitative data different botanical families (EFSA, 2016). on predation intensity, and proved to be suitable EFSA was then tasked by the European Commission for monitoring natural pest control. This method to periodically update the database to retrieve all the usefully expands the existing toolkit by directly new scientific developments published on the topic, measuring ecological function rather than structure. including information on results of experimental infections and on plant varietal responses. A systematic approach was applied for this update 92. Titanium dioxide nanoparticles according to the EFSA guidance on systematic and edible mussels: a potential literature review (EFSA, 2010) to collect the studies, select the relevant ones and extract the informative consumers’ exposure to nanoparticles? data. The results and conclusions of the new version of the Xylella spp. host plants global database will be GALLOCCHIO Federica presented. Istituto Zooprofilattico Sperimentale delle Venezie (IZSVe)

Bibliography Giancarlo Biancotto, Alessandra Moressa, Giuseppe EFSA (European Food Safety Authority), 2010. Application Arcangeli, Anna Toffan, Francesco Pascoli, Antonia Ricci – of systematic review methodology to food and feed safety IZSVe assessments to support decision making. EFSA Journal 2010;8(6):1637, 90 pp. doi:10.2903/j.efsa.2010.1637. Despite the widespread production and use of EFSA PLH Panel (EFSA Panel on Plant Health), 2015. Scientific engineered nanoparticles (NPs) and their foreseen Opinion on the risks to plant health posed by Xylella fastidiosa increased release into the aquatic environment, in the EU territory, with the identification and evaluation of risk reduction options. EFSA Journal 2015;13(1):3989, 262 pp., relatively little information is known about NP doi:10.2903/j.efsa.2015.3989. interaction with, bioaccumulation in or transfer to EFSA (European Food Safety Authority), 2016. Scientific report the aquatic food web. on the update of a database of host plants of Xylella fastidiosa: 20 November 2015. EFSA Journal 2016;14(2):4378, 40 pp. Due to the high diffraction index and strong light doi:10.2903/j.efsa.2016.4378 scattering and incident-light reflection capability, titanium dioxide (TiO2) NPs are widely used, mostly as white pigment in cosmetics, paints, dyes and varnishes, textiles, paper and plastics, food and drugs 91. Using artificial caterpillars to monitor and even paving stones. Indeed, evidence has been predation intensity in genetically collected of urban runoff water contamination by

modified maize TiO2 nanomaterial (NM). Aquatic ecosystems, such as the marine FERRANTE Marco environment, are therefore likely to be potential Aarhus University sinks for these NPs. Edible bivalve molluscs are known to be strong natural filtrating systems: by Marco Ferrante, Gabor L. Lovei, Serena Magagnoli, Lenka Minarcikova, Elena Larisa Tomescu, Giovanni Burgio, accumulating NPs, they might represent a potential Ludovit Cagan, Mihael Cristin Ichim vector of such contaminants and a consequent route of exposure of humans to NPs. Humankind draws important benefits from large- Therefore, in vivo studies, carried out by exposing scale ecological processes termed ecosystem mussels (Myrtillus galloprovincialis) to TiO NPs in services, yet the status of several of them is 2

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a controlled artificial marine environment, can give The Plant Health (PLH) Panel of the European Food important clues to understand NPs behaviour in the Safety Authority (EFSA) has a two-step approach aquatic environment as well as the bioaccumulation for its pest risk assessments: a pest categorisation of NPs in edible marine animals. is prepared in the first step and, if needed, a more detailed risk assessment is carried out in the second The detection and characterisation of NPs in step. The PLH Panel is currently performing a large marine environment and in marine species are number of plant pest categorisations (on bacteria, quite complicated due to NPs’ unpredictable fungi, viruses/viroids, insects, mites, nematodes and behaviour, fate and low concentrations. This parasitic plants included in the annexes of Council makes the determination of the bioavailability Directive 2000/29/EC). This work, in collaboration and bioaccumulation of NPs in marines species a with experts from throughout Europe, supports the challenge. However, a recently developed analytical ongoing revision of the EU plant health legislation. technique, known as single particle inductively Only for some selected pests, where more details are coupled plasma-mass spectrometry (spICP-MS), needed based on the categorisation, a quantitative represents a powerful and reliable tool for the risk assessment is performed on the request of the determination of NPs in complex matrices. By European Commission. For each pest categorisation, means of this analytical approach, the levels of criteria are assessed for consideration as a potential: contamination of mussels exposed to controlled concentrations of NPs can be determined and the Quarantine pest (absence in the EU, or (if present) analytical results can provide indication of potential under official control; ability to enter, establish, human exposure to NPs when mussels harvested in spread and cause impacts in the EU; availability of polluted environment are consumed. control measures). Regulated non-quarantine pest (presence in the EU; spread mainly via plants for planting rather than 93. Detailed vegetation maps as support natural dispersal; ability to cause impacts on the use of pest risk assessment: the case of plants for planting; availability of control measures of Xylella fastidiosa in Apulia (Italy) on this pathway). Protected zone quarantine pest (same criteria as for GARDI Ciro quarantine pests, but referred to a restricted and European Food Safety Authority (EFSA) geographically separated area of the EU, where the pest is still absent, e.g. the British Isles). Franco Ferilli – EFSA, ALPHA Unit (Trainee) Instead, for a pest risk assessment, quantitative The vast majority of pest modelling processes, models are developed to estimate the risk of entry, from the regional to the global scale, relies on land establishment, spread and impact. This poster cover maps for the definition of habitat suitability. provides an overview of the progress on the pest These maps however report only extremely categorisation mandate and the remaining work broad indications on the type of vegetation, and to complete the project. The relevance of the two- the possible extrapolation to the presence and step approach (1: pest categorisation; 2: quantitative abundance of a pest host plant are extremely weak risk assessment when needed) for making EFSA and uncertain. activities more fit for purpose will be highlighted. When available, vegetation maps with the indication of the dominant plant association, can significantly improve the accuracy in the definition of the habitat 95. Occurrence of deoxynivalenol in suitability. cereals and cereal products in Hungary In this poster we report the example of the application of ‘Carta della Natura’, a 1:250:000 KISKÓ Gabriella vegetation map of the Apulia region, for the Szent István University, Faculty of Food Science evaluation of habitat suitability for Xylella fastidiosa. Helga Tima, Adrienn Berkics, Zoltán Hannig, András Ittzés, The results have been validated using the data on Eleonóra Kecskésné Nagy, Andrea Taczmann-Brückner, the spread of Xylella in Apulia (Salento). Csilla Mohácsi-Farkas, Gabriella Kiskó

Due to changing climate-weather conditions, 94. EFSA plant pest categorisations: an similarly to other countries, Hungary has to count on seriously decreasing or missing crops, example of how to make risk assessment increasing contamination of cereals with moulds fit for purpose and, in connection with this, increasing mycotoxin contamination. One of the most important KERTESZ Virag mycotoxins that can often be found in crops is European Food Safety Authority (EFSA) deoxynivalenol (DON).

Ewelina Czwienczek, Ciro Gardi, Gabor Hollo, Tomasz The aim of our study was to monitor the DON Kaluski, Pautasso Marco – Animal & Plant Health Unit, contamination of cereal and cereal product samples EFSA in Hungary and combine these results with official Bernard Bottex, Scientific Committee & Emerging Risks recordings of the Hungarian Meteorological Country Unit, EFSA Service, to analyse the effect of weather data on

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DON contamination. the validity of the outcomes of the initial safety assessments that MON 810 has no adverse effects In this study, Hungarian wheat (n = 305), maize (n on human, animal health or the environment. The = 108), wheat flour (n = 179) and pasta (n = 226) samples MON 810 cultivation in the EU has provided efficient (collected during 2008–2015) were analysed (N = 818). protection against the target pests resulting in higher Enzyme-linked immunosorbent assay and liquid yielding crop, a significant decrease in insecticide use chromatography coupled with a mass spectrometry and a reduced susceptibility to diseases and pests were applied to determine DON toxin contamination. compared to conventional maize. The farmers’ high Among cereal samples, in 2011, wheat was compliance to the agronomic requirements for insect contaminated with DON (overall average ± SD; 2,159 resistance management (IRM), as established in the ± 2,818 μg kg−1), which was above the maximum harmonised IRM plan developed by industry in the EU, limit (ML). For wheat flour and pasta, no average has proven to be sufficient to sustain the efficacy of MON values above ML were found during 2008–2015, but 810 maize. The evidence above should be considered higher DON contamination could be observed in as valuable data in the risk management. The 2011 as well (wheat flour: 537 ± 573 μg kg−1; pasta: 511 absence of any indication of adverse effects over a ± 175 μg kg−1). decade of MON 810 cultivation invites the adaptation of the current monitoring practices. Based on our survey not only weather conditions, such as temperature, rainfall quantity and distribution, affect the level of DON toxin contamination of cereals and cereal products. A new risk factor – extremely 97. Quantitative pest risk assessment: dry weather, very low annual average rainfall the case of Spodoptera frugiperda quantity – was determined for wheat samples and very high yearly average temperatures for maize MacLEOD Alan samples. This highlights that consideration of other DEFRA extreme weather conditions is also needed when planning monitoring strategies. More than the Wopke van der Werf – Wageningen University, Ciro Gardi, previously determined weather conditions should ALPHA Unit, EFSA be consdered when monitoring matrix–DON toxin relationships. Following its introduction and rapid spread in sub-Saharan Africa, the European Commission asked EFSA to conduct a pest risk assessment of Spodoptera frugiperda (Lep: Noctuidae), the fall 96. Learnings from a meta-analysis armyworm, for the territory of the European Union. covering a decade of post-market S. frugiperda is a highly polyphagous pest from environmental monitoring of MON 810 the Americas and its favoured hosts are maize, rice maize cultivation in the European Union and sorghum. It has been intercepted in the EU on a range of fresh produce from the Americas LEE Ana Shein and more recently from Africa. The remit of the assessment was limited to the assessment of entry, Monsanto Europe establishment and risk reduction options. We will Tewodros Firdissa, Rocio Fernandez Canton, Lieselot present the quantitative assessment of entry into Bertho, Ivo Brants, Conchi Novillo, Kerstin Schmidt, specific EU NUTS 2 regions where climatic factors Graham Head – Monsanto indicate that establishment is likely to be possible. We will also present comparisons of the likelihood The controversial debate on the assessment of of entry via trade pathways with entry via migration genetically modified crops has led to over-regulation of adults on suitable air currents from sub-Saharan and restricted cultivation of MON 810 maize in the Africa using a recently developed quantitative European Union (EU). MON 810 maize produces the framework. It is recognised that the pest’s rapid insecticidal bacterial protein Cry1Ab which protects spread in Africa could lead to additional pathways the maize against European corn borer (Ostrinia originating in northern Africa, making entry into nubilalis) and Mediterranean corn borer (Sesamia the EU even more likely. The effect of risk reduction nonagrioides). The authorisation holder Monsanto options on lowering the likelihood of entry via trade has implemented the Post-Market Environmental will be presented. Monitoring (PMEM) of MON 810 cultivation in the EU using different tools including monitoring of target pests’ susceptibility, structured refuge compliance, farmer questionnaires, farmer complaint systems 98. Media and literature monitoring and assessment of scientific publications. The results on plant pests have been reported to the European Commission (EC) on a yearly basis, and the full PMEM reports MANNINO Maria Rosaria are available on the EC website. The present study French Ministry in charge of agriculture includes a meta-analysis of data from the PMEM reports collected in the period 2006–2015 based on 2 Franco Ferilli, Maria Rosaria Mannino, Giuseppe 627 farmer questionnaires across eight EU countries Stancanelli – EFSA and the assessment of more than 375 relevant published studies. The overall analysis confirms Abstract: Following a request from the European Commission (EC), EFSA provides monthly

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newsletters summarising media and literature to pesticides (e.g. EFSA 2010). The aim was to monitoring results obtained through a horizon operationalise the rather general environmental scanning procedure. protection goals as laid down in the European pesticide legislation. The aim is to identify relevant information on pests that can be of great interest for risk managers, plant In this contribution, we aim at illustrating the health specialists and civil society as well. challenges we recognise for the implementation of the ecosystem service concept in the risk Currently about 350 pests are monitored from assessment of pesticides considering the the EU legislation and EPPO lists. In addition, the uncertainties and knowledge gaps regarding the monitoring is active to retrieve information on new linkage between ecosystem services and biodiversity and unlisted plant pests. The media are screened and the limitations that arise for the protection of using the MEDISYS (Medical Information System) structural biodiversity. We argue that the ecosystem platform, developed by the General Directorate Joint services driven by non-target organisms in Research Centre of the EC. The items coming from agricultural landscapes should be addressed with the sources are filtered using categories with given a focus on their sustainable provision in space and key words to identify their plant health relevance. time. Co-occurring stressors, entangled community In total, MEDISYS retrieves and analyses more than interactions, knowledge gaps in species functions 200,000 items per day. Each monthly newsletter and the need of preserving sustainable systems contains: a summary of the main issues, the links to for the future are some of the features that may the articles, the publication date, the first lines of the well frame the dialogue on ecosystem services original articles, the automatic English translation of and protection goals in European agricultural the title and of the first lines. landscapes. The monitoring shows that plant pests are a highly discussed topic in the media and in literature. Many items retrieved by the tool refer to detection, 100. Mapping the environmental risk prevention and control of organisms harmful to the of Bacillus thuringiensis var. israelensis EU agricultural and environmental sectors. by the metabolic foot-printing approach The EFSA newsletter can be a useful tool to gather information and contribute to public awareness on PATIL Chandrashekhar plant health risks. University of Perpignan Via Domitia

Amani Ben Jrad, Hikmat Ghosson, Delphine Raviglione, Marie-Virginie Salvia, Cédric Bertrand – CRIOBE USR3278, 99. Protecting biodiversity from Université de Perpignan Via Domitia, F66860, France unacceptable pesticide effects through Presence and establishment of invasive mosquito the ecosystem service concept is more species such as Aedes aegypti and Aedes albopictus than challenging is rapidly increasing in the European environment. The European Directive in 1998 led to the increasing MATEZKI Steffen use of biological insecticides such as cry proteins Federal Environmental Agency Germany produced by the bacterium Bacillus thuringiensis var. israelensis (Bti) that kill mosquito larvae after Sabine Duquesne, Silvia Pieper, Klaus Swarowsky, Jörn being ingested. Considering the interest in Bti as a Wogram, Tobias Frische more environmentally sustainable bioinsecticide, it The ecosystem services concept was originally is important to examine in detail the environmental developed as an idea to increase the support for fate and impact of Bti. The available tool such as nature conservation by highlighting the benefits half-life, t½, does not considers the biodegradation that nature provides to human beings (Ehrlich & and biotransformation phenomenon of Ehrlich, 1981). However, during the last decade the complex formulations. To address this challenge, concept became increasingly attractive as central ‘Environmental Metabolic Foot-printing’ (EMF), idea behind approaches for the management giving an idea of the resilience time was recently of biodiversity and ecosystems (Costanza et al., developed in the laboratory (Patil et al. 2016; Salvia 1997, MEA, 2005). With the Millennium Ecosystem et al., 2017) to evaluate the impact of synthetic, Assessment in 2005 the first conceptual botanical and microbial insecticides on soil and framework with a classification scheme for sediment matrix respectively. ecosystem services has been published. Further The project ‘EnvFate’ aims to employ an conceptual developments followed and pushed EMF approach, to dynamically characterise the implementation of the concept into the policy environmental markers of Bti pollution found making forwards (Haines-Young and Potschin, 2010, among the sediment matrix meta-metabolome. De Groot et al., 2010, Luck et al., 2009). However, Metabolome characterisation will require the there exists also much deb (Mace, 2012, Cornell, 2011). development and optimisation of extraction and In 2010, EFSA proposed to adopt the concept to detection protocols using the LC-MS platform. In environmental risk assessment as a tool to identify addition, the metabarcoding approach will allow and communicate Specific Protection Goal us to understand microbial community responses options (SPG) for non-target organisms exposed to Bti pollution. Emphasis will be placed on better

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standardisation, data interpretation and evaluation compounds is soils and their potential leaching that will build confidence in the value of ’omics into groundwater is determined mainly by their technologies – this being essential to increase their physicochemical properties. (regulatory) use. These activities will advance our The soils contained multiple pesticide residues (e.g. understanding of environmental risks associated 53% of soils with ≥ 4 CUPs and/or TPs) the levels with Bti, and pave the way for the development and of which were noticeable (e.g. 7% of soils with ≥ 4 adaptation of new environmental monitoring tools. pesticide residues exceeding the threshold level of 10 We will present preliminary findings from µg/kg). Of the analysed pesticides, four compounds metabolomics data. The changes in the meta- were present in > 15% of the sampled soils at metabolome after Bti and α-cypermethrin concentrations exceeding the threshold level of 10 treatment is investigated at various time intervals µg/kg. These compounds included terbuthylazine- and compared with a control to evaluate the 2-hydroxy (80%) > epoxiconazole (56%) > atrazine-2- resilience time of the sediment. hydroxy (49%) > tebuconazole (40%) where the values in brackets show the overall number of positive soils at which the compounds were above the LOQ. 101. Robust estimates of winter loss In the groundwaters, pesticides based on in honey bees – an evaluation of data ethanesulfonic acids (ESA) and atrazine-based collected in Sweden herbicides were mostly observed. Several of the most frequently detected pesticides also exceeded the threshold level of 0.1 µg/L. These compounds SAHLIN Ullrika included alachlor ESA (23%), metazachlor ESA Lund University (19%) and metolachlor ESA (17%) where the values in brackets show the overall number of positive In Sweden, data on honey bee losses are currently samples at which the compounds were above the collected by voluntary reporting in three channels: threshold level. the Swedish beekeeping organisation, the Finally, because the high levels of water-soluble professional beekeeping organisation and COLOSS. pollutants in groundwaters can result in temporarily These data are not harmonised and there is no enhanced levels in surface and drinking water, the systematic analysis of winter losses, which can follow environmental and human health risk assessment trends or detect anomalies in different regions based on measured data were also provided. across Sweden. A recent evaluation of the quality of data and statistical properties from current data collection schemes show that data are heavily biased, that temporal and spatial variability in 103. iPlanta: modifying plants to produce losses are not properly understood, and that the interfering RNA aggregation of data influences the robustness of loss estimates. We give recommendations for how to SWEET Jeremy improve data collection and analyses of honey bee JT Environmental Consultants Ltd winter loss in Sweden. Prof. Bruno Mezzetti – Politechnic University Marche, Ancona, Italy

102. Comparison of pesticide residues Background: Methods to exploit plant defence in ground waters and agricultural lands mechanisms or changing plant metabolism by in Czech Republic RNA silencing show great potential. Interfering RNA can be used to improve plant composition ŠKULCOVÁ Lucia while enhancing levels of beneficial nutrients, Masaryk University and to improve plant productivity by suppressing undesirable traits and switching resources to more Jakub Hofman, Jana Vašíčková – Research Centre for beneficial quality and yield traits. Gene expression Toxic Compounds in the Environment (RECETOX), Faculty in pathogens and pests can be targeted and plants of Science, Masaryk University, Kamenice 753/5, Brno, CZ- modified to produce dsRNAs that trigger silencing 62500, Czech Republic and affect essential physiological functions in pest Vít Kodeš – Czech Hydrometeorological Institute (CHMI), or disease-causing organisms. Many of the modes Na Šabatce 2050/17, 143 00 Praha, Czech Republic of activity of the micro- and small interfering RNAs This study provides the first review of the national (miRNAs, siRNAs) that mediate the silencing effect occurrence of 64 currently used pesticides (CUPs) are not yet fully understood and knowledge of and their transformation products (TPs) in soils and systemic propagation, turnover, specificity etc. of groundwaters of Czech Republic. The pesticides these molecules is limited. were monitored in 2014–2017 at 216 agricultural Objectives: This COST Action will define and areas and at 689 groundwater monitoring sites. coordinate the most important research tasks Multiresidue analysis on LC-MS/MS was used for for the development of these novel transgenic determination and identification of the pesticides. strategies across many EU and nearby countries The resulting data for soil and water samples were with inputs from cooperating researchers in highly variable as the persistence of pesticide associated countries in North and South America,

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Australasia etc. pesticides and poor nutrition, at field-realistic exposures. We also demonstrated that combined Activities: chemical stresses synergistically impaired animal Evaluation of the efficacy of the RNA molecules for behaviour and survival. Because the stressors did the induction of disease and pest resistance and not cause significant effects individually, our results metabolic changes. suggest that the standard RA results could lead to underestimation of risks. The consequences for RA Examination of the specificity of the selected are discussed, as well as possible future directions miRNAs and siRNAs and their impacts on both towards an advancement of environmental RA that target and non-target/off-target systems. integrates multiple stressors. Developing specific risk assessment and risk management guidelines that relate specific effects of the miRNAs and siRNAs on food, feed and the Managing evidence environment. Understanding the modes of transmission, uptake, systemic spread and degradation of dsRNAs, 105. EFSA Knowledge and Innovation miRNAs and siRNAs. Community (KIC) on Exposure Science Determining the environmental and socioeconomic impacts of plant RNAi technology and products. CASCIO Claudia Communication through workshops, conferences EFSA, [email protected] and various media. D Arcella – Evidence Management Unit, EFSA Members: Scientists from 31 European countries. Levels of chemicals in food are an important aspect of food quality and safety. The assessment of dietary exposure to hazardous substances is a crucial component of the risk 104. Synergy as future challenge for risk assessment work carried out by EFSA’s Scientific Panels. assessment: pesticides, nutrition and In the last years, significant steps have been performed behaviour by EFSA in relation to the collection and standardisation of food consumption and chemical occurrence data TOSI Simone and in the development of new statistical methods University of California San Diego (e.g. probabilistic, cumulative, etc.) for the assessment of exposure. Projects (such as HMB4EU) and collaborations with national and international institutions (such as Animals are exposed to multiple stressors with the International Society of Exposure Science and simultaneously, such as pesticides (including ECHA) in the area of exposure assessments have been chemical mixtures of multiple active ingredients), established and training on dietary exposure assessment nutrition deficiencies and diseases. Combined delivered to both EFSA staff and experts. exposure to multiple stressors can cause interactive effects, amplifying the risk if the two agents (i.e. However, exposure science is moving from a single- two pesticides) interact synergistically on animal domain approach to a multidisciplinary efforts for the survival and behaviour. However, the Regulatory Risk characterisation of the ‘exposome’ as the totality of an Assessment (RA) generally evaluates the risks posed individual’s environmental exposures from conception by only one agent at the time (i.e. one pesticide), onwards. As the agency responsible for assessing the risk and mainly addresses effects on animal survival. of hazards in the food chain, EFSA needs to stay abreast The European Food Safety Authority (EFSA) has of these developments and further develop its exposure identified the RA of chemical mixtures as one of methodology taking into account non-dietary exposure its current priority tasks, but synergistic effects on and to ensure world class exposure methodology. animal behaviour, as well as synergies caused by In February 2018 EFSA initiated a Knowledge & non-pesticide stressors, are still currently not taken Innovation Community (KIC) on Exposure Science into account in the RA. The lack of appropriate with the aim to promote within and outside of EFSA: scientific studies and methodologies about (i) the exchange of knowledge in the area of human these key topics partially explains the respective exposure science; (ii) the exchange, integration and lack of advances in RA. However, the difference harmonisation of data and methodologies in the between the complexity of real world situations (i.e. areas of dietary exposure assessment, non-dietary exposure to multiple stressors affecting survival and exposure assessment, human biomonitoring; behaviour) and the simplified RA scenario leads to and (iii) collaboration between EFSA, EU Scientific uncertainties in RA conclusions. So, we developed Advice Agencies, research communities and other methodologies to assess synergistic effects of key stakeholders. The KIC on Exposure Science represents animal stressors on bee survival and behaviour. an opportunity for content-driven networking and Our work was based on the LD standard test, 50 brainstorming on new challenges in the field of which is already commonly used in RA, to facilitate exposure science among interested scientists. The implementation and comparisons. Honey bees were poster presents the KIC concept, activities and goals. used as RA animal model. Our work demonstrated that animal health can be synergistically impaired by the combination of two major common stressors,

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106. pestr – tools to mine EPPO Data Applied Scientific Research (TNO) Services with R It is part of EFSA’s remit in food and feed safety to evaluate the application of innovative technologies CZYZ Michal to support the identification of emerging risks. Institute of Plant Protection, National Research Institute This pilot project aimed to assess the applicability and capability of the Emerging Risk Identification Maciej Otworowski – Infant Jesus Teaching Hospital, Support System (ERIS), developed by The Medical University of Warsaw, Lindleya 4, 02-005 Netherlands Organisation for Applied Scientific Warszawa, Poland Research (TNO), to identify emerging hazards in the Atlantic salmon (Salmo salar) and pacific oyster One of the basic procedures in every risk assessment (Crassostrea gigas). ERIS applies text mining rules is extracting information from online resources. to identify grammatical and contextual relationships Assessors without programming skills are often in article titles and abstracts, between potential struggling with time-consuming and boring hazards, effects and exposure. procedures for finding relevant information and copy–pasting it into their reports. What is even more During the pilot phase, ERIS’ ontology was adapted problematic is the fact that this procedure is error in an iterative and interactive process according prone and non-reproducible. Many of the databases EFSA’s needs followed by a blind trial to align the offer an application programming interface (API) expert’s evaluation from EFSA and TNO. In the that, when correctly used, allows reproducibility, second phase the text mining tool was applied to saves time and limits errors. abstracts from two different databases MEDLINE®/ PubMed® and FSTA®, published January 2015-June Some other databases are more complicated as 2016. The output was evaluated by experts to identify their APIs have limited use. So, to use full spectrum potential emerging risks according to an accepted of information stored, other techniques (e.g. SQL quality assured protocol based on a multieye queries or web-scraping) are necessary. One of the principle including a benchmark of the relationships examples of databases that require a broad set found against a database containing scientific of tools to receive information is the EPPO data literature of 10 years (2005–2014). services. It is one of the most important information resources for pest risk assessors in Europe. To ERIS processed 1,821,576 abstracts and retrieved 707 extract different types of information on pests abstracts (422 for salmon and 285 for oyster). After a and hosts, one needs to use SQL queries, REST first round of expert evaluation, 67 articles for salmon (REpresentational State Transfer) API and web- and 47 for oyster were pre-selected. A second round scraping. Moreover, data obtained from web services of expert evaluation comparing the pre-selected are stored in machine-friendly formats, which abstracts with the benchmark lead to 28 potential are difficult to read by humans. The broadness of emerging risks identified; 18 in salmon and 10 in techniques might overwhelm assessors with no to oyster. Although significant resources were invested limited programming skills. from EFSA and TNO to improve the precision of the ERIS tool in identifying potential emerging Here we present a package of R functions to easily risks, ERIS has been proven to be a valuable tool receive information from EPPO data services and to automatically select relevant research abstracts to use them to create human-readable tables. allowing the identification of potential emerging Advanced users will be able to use this function to risks from a trusted and manageable data set after automatise filling standardised risk assessment expert evaluation. reports with basic information on investigated pests. Moreover, it will also help risk managers to quickly Key words: emerging risk identification; text mining; ontology; semantic relationship, food safety; expert evaluation; salmon; build tables with information on multiple species for oyster. comparison and communication of potential risk.

108. A systematic review comparing 107. Identification of potential emerging the zebrafish embryotoxicity test risks in the salmon and oyster food chain and mammalian developmental toxicity tests – piloting an innovative text mining tool HOFFMANN Sebastian GARCIA MATAS Raquel Evidence-based Toxicology Collaboration (EBTC) EFSA Sevcan Gül Akgün-Ölmez – Marmara University, Turkey Raquel Garcia Matas (Scientific Officer), Caroline Merten Rob de Vries – Evidence-based Toxicology Collaboration (Scientific Officer), Yves Van der Stede (Scientific Officer), Ana Afonso (Team Leader) – Unit on Scientific Committee Martin Stephens – Evidence-based Toxicology Collaboration and Emerging Risk (SCER), Risk Assessment and Scientific Hilda Witters – VITO, Belgium Assistance Department (EFSA) Rob Wright –Johns Hopkins Medical Institution, USA Niels B. Lucas Luijckx (Consultant Risk Management Food Katya Tsaioun – Evidence-based Toxicology Collaboration Safety), Fred J. van de Brug (Scientist Knowledge Mining), Winfried R. Leeman (Scientist Toxicology), Jos M.B.M. The Evidence-based Toxicology Collaboration (EBTC) van der Vossen (Scientist Microbiology), Hilde J. Cnossen is exploring the novel application of systematic (Project Manager) – The Netherlands Organisation for review (SR) methodology to comparisons of the

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performance of toxicity test methods. An SR group, which may have impact on the exposure of which covered the required areas of expertise, was consumers. Therefore, in 2011 EFSA launched the convened. The group systematically compared ‘What’s on the Menu in Europe? – EU Menu’ project, the standard in vivo prenatal developmental with the aim of providing financial and technical toxicity test in rats and rabbits (similar or identical support to MS and pre-accession countries to carry to Test Guideline 414 of the Organisation for out a dietary survey at national level. Economic Cooperation and Development), i.e. the The methodology used in the national food comparator test, with the zebrafish embryotoxicity consumption surveys is expected to follow the test (ZET) as the index test. The SR focused on principles described in the EFSA Guidance on the malformations as the outcomes, which expressed EU Menu methodology, published in 2009 and as a dichotomous variable, i.e. as the presence or updated in 2014. It focuses on collecting data from absence of malformations. First, an SR protocol six population groups, ranging in age from 3 months was finalised and registered at PROSPERO, based to 74 years with a harmonised methodology and on the learnings of a pilot study. Second, we has been endorsed by the EU institutions through conducted a comprehensive search of the ZET EFSA Network on Food Consumption Data. EFSA literature to identify chemicals in eligible studies, is currently supporting dietary surveys on children resulting in 1,436 chemicals in 342 studies. In this and/or adults from 21 countries. The projects are step, the unstructured format of abstracts and expected to be finalised by 2022. the heterogeneity in the reported ZET protocols posed the main challenges. Third, a search was conducted to identify mammalian studies on these chemicals. Here, the major obstacle was to 110. FoodEx2 – an international food efficiently incorporate the desired chemicals in the classification and description standard search. When standard SR methodology needed for describing data collections to be adapted to the task of toxicological test method comparison, the group ensured that the IOANNIDOU Sofia solution still abided by the evidence-based principles EFSA, Evidence Management Unit of transparency, objectivity and reproducibility. The project is entering the final SR steps of data extraction Valentino Avon, Davide Arcella – EFSA, Evidence and analysis. We can provisionally conclude that SR will Management Unit be a valuable tool for evaluating available evidence on test method performance. A strategic objective of EFSA is to enhance the quality of its outputs by giving direct access to data, promoting the development of international collaborative platforms and fostering data re-use 109. EU Menu: experiences and perspectives and innovation. In this remit, the use of common data standards is a prerequisite to improve data HORVATH Zsuzsanna interoperability and facilitate data sharing and EFSA exchange. In particular, a standardised system for classifying and describing food is essential Sofia, Ioannidou, Davide Arcella – Evidence Management to compare data from different domains and Unit, EFSA perform more detailed data analysis. To this aim, Since 2005, the European Food Safety Authority EFSA developed FoodEx2, a standardised food (EFSA) has worked in close cooperation with classification and description system. This is a all organisations operating in the field towards comprehensive standard aimed at describing food harmonising dietary survey methodology and in data collections across different domains. building a common European Union (EU) FoodEx2 consists of descriptions of a large number food consumption database. Harmonised food of individual food items aggregated into food groups consumption data are the basis for improving and broader food categories in a hierarchical parent– accuracy of EU-wide exposure assessments and child relationship structure. The description of can also assist in serving the needs of nutrition individual foods can be complemented by additional surveillance and of further diet and health related information through the use of facets. studies. Improved risk assessments can assure more targeted risk management and permit more After its first release in 2011, FoodEx2 was intensively accurate risk communication resulting in increased tested with regard to the collection of food consumer confidence. consumption and chemical occurrence data and this involved several EU Member State organisations The first step in this direction was the development operating in data collection. The testing highlighted of the EFSA Comprehensive European Food strengths and weaknesses of the system and Consumption Database which compiles existing provided suggestions for improvement. As a national dietary information from the Member consequence, FoodEx2 was reviewed and revised to States (MS). MS used different methods to collect match the needs expressed by the different users. food consumption data, which makes it difficult to carry out EU-wide analyses or country-to-country FoodEx2 is already used by Member States when comparisons. Furthermore, there is a need to exchanging data with EFSA. In addition, it boasts an regularly update the available information, as the international reach with the Food and Agriculture consumption patterns are continuously changing Organisation and the World Health Organisation

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using FoodEx2 to facilitate the collection of food 112. The Raw Primary Commodity (RPC) consumption and food composition data on a global Model level. EFSA is engaged in improving and promoting best practice regarding its use. FoodEx2 is freely KIRWAN Laura available for download and use. EFSA

Bruno Dujardin – EFSA

111. Refined risk assessment using EFSA’s dietary exposure assessments to chemicals ImproRisk are informed by both dietary consumption data and chemical occurrence data. Dietary consumption KAFOURIS Demetris data are stored in EFSA’s Comprehensive State General Laboratory European Food Consumption Database and are formatted either as composite foods or as Raw Georgios Stavroulakis, Christopher Papachrysostomou, Primary Commodity (RPC) derivatives (i.e. food Lefkios Paikousis, Maro Christodoulidou, Stelios ingredients). In several food sector areas however, Yiannopoulos – Risk Assessment Unit, State General Laboratory (SGL), Ministry of Health, Nicosia, Cyprus chemical occurrence data are reported to EFSA for the RPC. These can be provided either through ImproRisk, an excel-based model, is a tool for EU monitoring programmes or within a specific conducting rapid risk assessment analysis. It is an regulatory framework as trial data. In these cases, empirical distribution model using the deterministic the dietary consumption data available in the EFSA method of dietary exposure assessment to Comprehensive Database are not compatible contaminants. Its most important feature is with the chemical occurrence data provided. The the derivation of probability and cumulative objective of the RPC model is to facilitate the distributions of exposure. The model has been standardised conversion of dietary consumption upgraded to meet the needs of risk assessors within data for composite foods and RPC derivatives the EU and the non-member countries. It abridges into their corresponding amounts of RPC. The the gap between screening and probabilistic RPC model functions in three main steps. In the models and is compatible to the approach applied adjustment step, the classification of the initial by EFSA for dietary exposure assessment. The model consumption data are optimised for disaggregation. can easily be applied to food additives and other In the disaggregation step, the adjusted foods chemicals. It is a simple, straightforward and a user- are disassembled into their RPC derivatives, friendly model, validated by EFSA. with a probability analysis step employed where required. In the final conversion step, descriptive ImproRisk combines Food Consumption Data with facets are allocated to the RPC derivatives and the Occurrence Data and calculates the exposure rate initial amount of RPC required to produce each for the population of interest. The model embeds RPC derivative is estimated through the use of the EFSA FoodEx system version 1. It has the capacity reverse yield factors. A cross-check was executed to work with individual Food Consumption Data; against the RPC consumption estimates currently therefore, it supports exposure calculation at each used in the area of feed additives and pesticides. food consumption instance. Overall, the consumption outputs of the model The capacity of the model to use Occurrence Data were consistent with previous estimates. The at FoodEx Level 3 makes the exposure assessments availability of the Comprehensive Database at quite refined. This is shown in the estimation various consumption levels will enhance EFSA’s of the dietary intake of Aflatoxin B1, which has capacity to utilise the Comprehensive Database in been recently conducted in Cyprus. Aflatoxin B1 areas where it is not currently applicable, allowing occurrence data in 1,231 food samples, for the years for the implementation of more proficient exposure 2006–2015, were used for the calculation of the assessment methodologies in the future. dietary exposure. The exposure calculation was performed and compared, using both Occurrence Data at FoodEx Level 2 and Level 3. To carry out risk 113. An adaptive, mechanistic and quantitative characterisation, the Margin of Exposure (MOE) approach for plant pest risk assessment approach was applied. The calculated MOE values for Aflatoxin B1 were substantially lower than 10,000, indicating a health concern for carcinogenicity. The KOZELSKA Svetla highest contribution of exposure was observed EFSA for nuts, cereals and spices. The results were Gianni Gilioli, Alan MacLeod, Roel Potting, Trond Rafoss, comparable with the findings of EFSA and other Wopke Van Der Werf, Andy Hart, Jan Schans, Gritta research groups. Schrader, Svetla Kozelska, Maria Rosaria Mannino, Olaf Mosbach-Schulz, Sybren Vos

Plant pest risk assessment at EFSA consists of two phases: (i) a pest categorisation; and, if needed, (ii) a more detailed risk assessment. For the second phase, the EFSA Plant Health Panel developed a novel approach for quantitative pest

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risk assessment which increases the transparency assessment system to use ICF for a holistic and objectivity of the process. This methodological assessment of patient needs and priorities. framework is based on three pillars: Results: About 120 individuals have participated in pilot An adaptive approach (scenario-based analyses Cypriot biomonitoring studies and more than 4,000 have and conditional assessments). For ensuring fit-for- been enrolled in the ICF-based national disability registry purpose risk assessment, special care is given to the to this date. Participation rates have been more than 60% problem formulation, with interactions between the for both processes, which are among the best compared requestor of the assessment and the risk assessors. to other EU countries using comparable approaches. During this activity, the risk assessment scenarios are Information from these databases has already been used chosen and the risk assessment strategy is defined to adapt national legislation and regional health and based on the available resources and data. nutrition measures resulting in improved satisfaction and more efficient resource allocation. A mechanistic and population-based approach (the risk assessment model is based on the biology of Discussion: Health and nutrition public health the pest, in particular on the pest abundance). For policies have to surpass resistance and financial each assessment a model is developed estimating barriers to be effectively applied. The use of pest abundance from the place of production in the comprehensive and comparable needs assessment country of origin to the endangered area in the EU. data can facilitate raising public awareness and coordinating different services towards the A quantitative and evidence-based approach (expression achievement of improved outcomes. of the model parameters as probability distributions integrating both risk estimates and related uncertainties). Pest entry, establishment, spread and impact may be assessed directly, using weight of evidence and expert 115. In situ spectral sensing to support knowledge. Each assessment model is developed using evidence-based risk assessment for food Monte Carlo simulations, which can compare scenarios safety, traceability and authenticity for relevant factors, e.g. with or without risk reduction options (RRO). Comparisons between scenarios are MISHRA Puneet made to draw conclusions on the magnitude of pest University of Strathclyde risks and the effectiveness of RRO. This new approach is detailed in the PLH Guidance Alison Nordon – WestCHEM, Department of Pure and Applied Chemistry and Centre for Process Analytics and Document for quantitative pest risk assessment Control Technology, University of Strathclyde, Glasgow, G1 that provides explanations on the application of 1XL, United Kingdom the two-phase assessment method and on how to communicate its results. In situ generation of chemical information for food products can enhance the risk assessment task performed for food safety, traceability and 114. Use of human biomonitoring data authenticity issues. Due to the recent development of advanced optics, different modes of molecular and ICF classification to develop targeted spectroscopy such as visible (VIS) and near-infrared vertical public health policies (NIR) can be deployed rapidly and in real time. Even miniature sensors for molecular spectroscopy can LAVRANOS Giagkos be combined with smartphones to support data European University Cyprus/Ministry of Health acquisition. Further, advanced chemometic analysis can be performed to derive conclusions from the Andromachi Katsonouri – State General Laboratory data recorded by the sensors. The information Christina Flourentzou – Ministry of Labor, Cyprus provided by the techniques can be used to perform non-destructive classification and chemical Introduction: Human biomonitoring is a relatively composition estimation, which can potentially new scientific field aiming at the detection support rapid generation of evidence for assessing of potentially hazardous chemicals and their the risk for cases of food safety, traceability and metabolites in human biological samples and their authenticity. In the present poster, application of association with undesirable health outcomes. a miniature mobile phone operated NIR spectral Despite gradual accumulation of experience and sensor is presented for locating the geographic harmonisation initiatives, no uniform approach origin of green tea products originating from seven exists at an EU level yet, resulting in significant different parts of the world. It was possible to locate variance in priority areas and populations, screening the geographical origin of the samples based on algorithms or result communication. The aim of the NIR spectral signatures and chemometrics this presentation is to present existing Cypriot modelling. Furthermore, black cut–tear–curl (CTC) experience in human biomonitoring and its teas with known chemical profile differences could potential implication for focused policy making be classified using a hierarchy of similarities using Materials and methods: Since 2013 Cyprus has the same sensor. In conclusion, miniature spectral participated in a number of consortia to develop sensors could support in in situ evidence generation and apply harmonised human biomonitoring for food risk assessment. studies along with most other EU Member States. At the same time, it has restructured its disability

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116. Increasing transparency with Corrado Lanera, Dario Gregori, Luca Nicolandi – Unità di Biostatistica, Epidemiologia e Sanità Pubblica del Knowledge Junction Dipartimento di Scienze Cardiologiche, Toraciche e Vascolari dell’Università degli Studi di Padova RINGWALD Friedemann Barbara Bonifacio – Zeta Research s.r.l., Trieste EFSA José Cortiñas Abrahantes – Assessment and Methodological Support Unit, European Food Safety Authority, Parma, Italy Citlali Pintado, Jane Richardson, Ivana Marsic, Barnabas Czomba, EFSA Introduction: In 2014, EFSA commissioned an evaluation of the potential use of machine learning techniques Open government data relates to the wide and (MLT) within EFSA’s assessments. A specific aim was free availability of public information created or to classify the risk questions (RQs) asked to EFSA and collected by public entities. The availability of identify the statistical techniques (ST) applied. datasets to citizens improves the transparency and accountability of public institutions. Governmental Materials and Methods: All 3,744 EFSA Opinions promotion of the use, re-use and free distribution of published up to 2014 were retrieved and converted datasets may result in an improved understanding into a dataset based on a dictionary of 15,475 of their work, the formation of new businesses words. Both Latent Dirichlet Allocation (LDA) and and creation of innovative services. Food and feed Correlated Topic Modelling (CTM) were used to safety organisations in EU Member States are at create two separate sets of 20 topics, each of these various stages of open government data adoption. built up of a cluster of 100 ranked words. Meaningful The International Open Data Charter and the FAIR themes, as proxies of the RQs, were recognised by data principles (Findable, Accessible, Interoperable, inspecting each topic. The two 20-topic outputs Reusable) function to advance public understanding were compared through Spearman’s rho to of the European Food Safety Authority’s (EFSA) identify any overlapping. A vocabulary of statistical scientific work through the availability of scientific techniques was developed and used for further text data to citizens. mining and matching STs to RQs. Finally, how 12 main statistical approaches were used to address 10 EFSA is striving to move beyond existing data main themes was investigated by a questionnaire to limitation rules. The publication of scientific data 49 EFSA staff from all Panels and Units. will allow EFSA to move towards an open by default approach. EFSA aims to employ a proactive Results: The combination of the LDA and CTM publication process which publishes scientific 20-topic series resulted in a total of 28 distinct outputs, related data and associated data in the main themes, easily recognisable within the remits Scientific Data Warehouse (SDWH), in line with of EFSA. The top-five themes were: MRL setting/ the General Data Protection Regulation (GDPR). revision; safety/efficacy evaluation of additives/ These will be available in Knowledge Junction (KJ), ingredients; health claims evaluation; pesticides peer an open evidence community. KJ is a curated, review; flavouring toxicity evaluation. In total, 829 open repository for the exchange of evidence and EFSA Opinions showed the application of statistical supporting materials used in food and feed safety techniques, with meta-analysis, ANOVA, benchmark risk assessments. In this repository, publications will dose methods, linear regression, ROC modelling, be assigned a Digital Object Identifier to enable the simulation methods, logistic regression, generalised identification, traceability and relatability of scientific linear models and dose–response models outputs and datasets. The process of publication has accounting for 80% of all statistical methods applied. already started in EFSA. The team-specific use of statistical approaches to address the main themes was shown through Public availability of datasets used in EFSA’s Sankey diagrams. scientific outputs will result in an improved public awareness, understanding and trust in EFSA’s Conclusion: As an added value of the EFSA scientific work. assessments, a large collection of texts was made available for further analysis: MLTs applied on such a large amount of unstructured text provided a fruitful 117. The meaningful vocabulary of EFSA: insight of the EFSA assessment process. mapping its risk assessment activities through a text analysis of 3,744 Opinions issued by EFSA up to 2014 118. Review of the national control plan

RU Giuseppe SCHRAP Marca Istituto Zooprofilattico Sperimentale del Piemonte, Liguria Netherlands Food and Consumer Product Safety Authority e Valle d’Aosta, TSE National Reference Laboratory, Torino, ED van Asselt, MY Noordam, MG Pikkemaat – RIKILT Italy Wageningen University & Research

Cristiana Maurella, Maria Ines Crescio, Francesco The purpose of this study was to devise an action Ingravalle – Istituto Zooprofilattico Sperimentale del plan for a more risk-based implementation of the Piemonte, Liguria e Valle d’Aosta, TSE National Reference Laboratory, Torino, Italy National Plan for Residues (NPR) (Directive 96/23/ EC) to comply with the new Control Regulation ((EC) Paola Berchialla, Silvio Mercadante – Dipartimento di Scienze Cliniche e Biologiche dell’Università degli Studi di Torino, Italy No. 882/2004). The study examines the extent to

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which monitoring can be made more effective and websites, blogs, social network) and collect relevant efficient. contents referring to food risks, among which the ones dealing with fipronil were selected and By developing a risk-based monitoring programme, analysed. Data on fipronil were gathered from July current monitoring can be made more effective. 2017 to February 2018. Data analysis defined: how Therefore three decision trees were created: (I) much the fipronil incident was discussed online prohibited substances; (II) contaminants, natural (numbers of relevant mentions); which online substances and pesticide residues; and (III) sources preferably talked about the incident; which substances authorised for veterinary drugs and feed aspects received major attention in coverage and additives. These decision trees can be used to classify online users’ engagement; which figures (e.g. substances, per type of animal, as having ‘high’, politics, research institutions, associations,…) were ‘medium’ or ‘low’ priority for inclusion in the NPR. mainly mentioned in the online debate. Moreover, the study examines whether current This study served to assess to which information monitoring could be made more efficient by pooling online users have been exposed, possibly influencing samples. Calculations were performed on the basis risk perception and attitude towards the fipronil of the current monitoring data and experiments incident, and how much they engaged with. with cattle urine enriched with β-agonists. Both Results suggest that web monitoring techniques the calculations and the experiments showed that, can be a valid tool to manage data referring to for some substances, up to five samples could be food risk communication, as they provide public pooled, whereas a maximum of two samples could health authorities with data and useful evidence- be pooled for substances whose detection limit is based insights to infer what happens in crisis close to the legal limit. communication and how it works. The study also looked at the identification of emerging risks. An analytical approach to emerging risks is possible by using broad screening 120. SIGMA – EFSA comprehensive animal techniques, which also allow retrospective searches. disease data collection This risk-based monitoring plan has to be updated every year on the basis of acquired knowledge ZANCANARO Gabriele and analytical findings. Moreover, some of the EFSA monitoring has to be performed on a random basis to ensure that hazards are not overlooked. It is M Monguidi, A Broglia, S Dhollander, F Baldinelli, A Gogin, recommended that broad screening methods be N Križ, F Verdonck used that not only detect prioritised substances but also have a broader focus, so that emerging risks can Risk assessors are being asked to provide better be detected. technical support to risk managers in the field of animal diseases after limitations were identified during recent outbreaks of animal diseases in Europe. The European Food Safety Authority (EFSA) 119. Big data and food risk therefore decided to harmonise data collection communication. Analysis of the online activities related to animal disease outbreaks and debate on fipronil using the web disease surveillance. The result will benefit all monitoring technique involved stakeholders: EFSA will have high quality and up-to-date data, risk managers will get timely TIOZZO Barbara and robust scientific advice, Member States will Istituto Zooprofilattico Sperimentale delle Venezie be able to query the data they submitted, produce national reports, and have an overview of the Mirko Ruzza, Mosè Giaretta, Claudio Mantovani, Licia European situation in ‘real time’. Ravarotto – Istituto Zooprofilattico Sperimentale delle Venezie, Padova, Italy The foundation of this harmonisation process will be a unique EFSA Animal Disease Data Model as Fipronil is an insecticide that is banned by the part of a project called SIGMA (σ-ADM). Once the European Union for food production for human σ-ADM is established, EFSA will work together with consumption. However, in August 2017, 15 EU the Member States, as part of the SIGMA project, Member States were found to have imported to improve and automate the flow of data from the fipronil-contaminated chicken eggs, as the national databases to EFSA’s Data Warehouse. The substance had been illegally used in the production idea is to automatically extract, upon agreement chain. The incident rapidly raised public health with the MSs, the relevant data and transform those authorities’ and consumers’ concerns, which was data so that they match the σ-ADM. This approach matched with an abundant coverage of the event in means the Member States do not have to modify the online media arena. the way they work. The data will be then pre- validated by the data provider and uploaded to the To this extent, web monitoring techniques and EFSA Data Collection Framework (DCF) for analysis. content analysis methods were used to analyse food risk communication about the fipronil incident. Based on a system of key words and rules, a web monitoring application was instructed to automatically monitor online sources (e.g. news

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Engaging with society 124. Food safety communication strategy in the Basque country

121. DecodE – An integrated approach DE ARIÑO Amaia to improve awareness and aid transition Elika – Basque Foundation for Food Safety to natural additives in collaboration with Loreto Rubio – Sinergia-Value the food industry The consumer perception on Food Safety depends CAROCHO Márcio mostly on the ways in which the information is received. Therefore, it becomes essential to establish Polytechnic Institute of Bragança a communication strategy carefully planned and Márcio Carocho, Maria Filomena Barreiro – Mountain based on a proactive and anticipatory focus. Research Centre (CIMO), Polytechnic Institute of Bragança, Portugal, Laboratory of Separation and Reaction In every situation, during current times or crisis Engineering – Laboratory of Catalysis and Materials (LSRE- times, the communication strategic guidelines LCM), Faculty of Engineering, University of Porto, Portugal must be oriented to answer WHAT, WHO, WHERE Filipa S Reis, Lillian Barros, Isabel CFR Ferreira –Mountain and HOW it is going to be performed. So, the Research Centre (CIMO), Polytechnic Institute of Bragança, coordination and collaboration of governments, food Portugal producers, consumers and other stakeholders along Alírio Rodrigues – Laboratory of Separation and Reaction the food chain is needed to exchange information Engineering – Laboratory of Catalysis and Materials (LSRE- and knowledge. LCM), Faculty of Engineering, University of Porto, Portugal In this paper, the work performed in the Basque Recent studies indicate that consumers have a country to establish a collaborative and joint strategy higher awareness of what they eat and are paying to face Food Safety Communication is presented. more attention to labels to consume healthier food. The methodology used has been displayed as For food additives, there is still a high percentage workshops and seminars where several tools of the population that does not understand their have been developed among the risks assessors, different classes, or origin (natural or artificial), along managers and communication coordinators, with many misconceptions. In line with consumer’s previously identified. volition to reduce the consumption of processed The steps as follows: foods and their tendency to prefer them non- or minimally processed, the DecodE project aims First of all, the food safety topics have been classified to help clarify the mystification of food additives, according to the risk origin, food related to and the helping consumers and the general public know public health effects, considering that the way of the differences between them, their implications facing communication is different in each case. on food and especially, their impact on consumer In a second phase, an ‘internal reply note’ has health. Furthermore, DecodE also aims at helping been designed as a tool to identify all the relevant the gradual transition from artificial to natural information on the topic and to agree on a common preservatives and colourants, with research being message to communicate. That note becomes a carried out on both topics. This is performed in practical and useful tool to support the management close collaboration with pastries and bakeries to of the communication in a crisis situation. help substitute the artificial additives used in these industries, and create sustainable methods of Finally, a communication protocol for crisis situations obtaining safe natural counterparts to be gradually has been developed. This protocol helps to share introduced into the market, so, reducing their information and to assess the crisis in a coordinated drawbacks, namely stability, high obtainment way by the risk managers. cost and low efficacy. All this is carried out in an Overall, the Food Safety Communication Strategy integrated framework based on the cumulative in Basque Country helps to prepare a unique knowledge of the research centre where the project and common message addressed to the Basque is being executed, the Mountain Research Centre in population to guarantee their trust and credibility on Bragança, Portugal (www.cimo.ipb.pt), supported by various researchers with expertise in different topics. the food safety information received. One of the main focuses of the project is to be open to society, hence the open data strategy, to reduce the gap between scientific data and the public’s knowledge of important aspects regarding their food. The authors are grateful to the Foundation for Science and Technology (FCT, Portugal) and FEDER under Programme PT2020 for financial support to CIMO (UID/AGR/00690/2013). This work is funded by the European Structural and Investment Funds (FEEI) through the Regional Operational Programme North 2020, within the scope of Project NORTE-01–0145- FEDER-023289: DeCodE. Márcio Carocho thanks FCT for his post-doc grant SFRH/BPD/114650/2016 122. 123. Pr

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125. Media portrayal of GM food in the light coli) and less considered by the media (e.g. Anisakis). of Brexit: a qualitative content analysis In the literature there are already attempts to define of British newspaper articles newsworthiness key points for food risk but still they need to be tested extensively on corpora. To this end, the analysis starts from the new project ‘Food Media FABRIZI Roberta Monitor’ deriving from the collaboration within the University of Sheffield activities of TIPS project between the University of Padua and the University of Gastronomic Sciences. Jean Russell – Corporate Information and Computing Services, University of Sheffield The analysis matches Italian and English daily press to add a further level of interest: international Jurriaan Ton – Department of Animal and Plant Sciences, University of Sheffield comparison to highlight different cultural frames about food risk and food safety. Margo Barker – Food and Nutrition Group, Sheffield Hallam University

Genetically modified organisms (GMOs) are a 127. Human biomonitoring – an essential controversial topic. In the past, the media has been implicated in shaping public attitudes to GMOs by tool for effective risk management: a case sensational reporting and polarisation of the debate. study from Cyprus This study examines portrayal of GM food in British print and digital newspapers in relation to reporting KATSONOURI Andromachi of Brexit negotiations. A qualitative content analysis State General Laboratory, Ministry of Health has revealed an alignment between anti-GM food and anti-Brexit sentiment. It was unusual to find Ioanna Gregoriou, Maria Aletrari, Maro Christodoulidou, Alecos Agathangelou, Anna Demetriou, Kateirna Konari, articles that were pro-GM food and anti-Brexit. GM Maria Zaoura, Natasa Papagianni, Makris C. Konstatninos, food largely appeared in anti-Brexit articles and Pavlou Pavlos was often positioned alongside other controversial North American food manufacturing practices. So Groundwater in Cyprus is a valuable natural resource GM food carried negative sentiment in the context for human consumption and as such is routinely of a possible post-Brexit trade deal with the United monitored. In 2009, levels exceeding the permitted States. Furthermore, articles which put forwards level of arsenic were found in the drinking water both pro- and anti-GM food arguments showed a supply of a small community (legal limit: 10 μg clear contrast in the language used; anti-GM food As/L, found: 18–19 μg As/L), causing great anxiety and sentiment tended to be expressed using hyperbolic fear among inhabitants. The government language in contrast to the rational tone of pro-GM took immediate action by terminating the water food writing. supply from the contaminated boreholes and supplying clean drinking water to the community. These results show how GM food is still carrying For effective risk management, the Ministers of negative connotations and, in the context of Brexit, is Environment and Health mandated respective used to support political agendas. scientific committees to investigate the situation and support policy decision-making. The authorities were in close communication with the affected 126. Food risk and safety newsworthiness: community throughout the investigation and an comparing contexts and differently expert appointed by the inhabitants represented covered alarms them in the scientific committees. The environmental committee found the pollution sources to be both natural (occurring in bedrock) GIARDULLO Paolo and man-made (byproducts from animal Department of Philosophy, Sociology, Education and farming, light industry). The medical committee Applied Psychology, University of Padua assessed residents’ exposure using toenail arsenic biomonitoring (statistically increased compared Food risk is a well renowned issue in the media. to a control community, but well below health- Since the BSE crisis daily news has dedicated a guidance values) and possible health effects by considerable amount of coverage about food risk dermatological examination of a representative alarms. Nonetheless, not every single food risk sample of residents (no pathologies found) and by case becomes a news story. Media theory about comparing cancer incidence in the community to newsworthiness traditionally frames such a process the rest of Cyprus (no increased incidence). The of agenda setting. To deepen evidence about food results were communicated by the Ministers at press risk and food safety it is necessary to go beyond the conferences and directly to the inhabitants in visits mere count of articles, namely to move further trend to the community, giving the opportunity for analysis about news coverage. Rather it is worth discussions. A layman leaflet summarising the concentrating on features of a set of news about findings and giving related information was also specific alarms. This is to try to understand how distributed. The government announced that the risks that have been more covered are different although no health effects were expected, the – and about what – from those covered less. The community would continue to be followed poster relies on the comparison of narrative frames for possible future medical occurrences. Prompt about the highly covered alarms (e.g. Escherichia governmental response, societal engagement

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and solid scientific support of decision-making 129. Consumer awareness in Greece were instrumental to building citizens’ trust in the of issues of antibiotic use and the risk authorities’ risk management actions. of antimicrobial resistance in bacteria

LIKOTRAFITI Eleni 128. Consumer information Laboratory of Food Microbiology, Department of Food on the prevention of microbiological Technology, Alexander Technological Educational Institute risks: assessment of the effectiveness of Thessaloniki, Greece of communication strategies Elena A Oniciuc – Faculty of Food Science and Engineering, Dunarea de Jos University of Galati, Galati, KOOH Pauline Romania ANSES Miguel Prieto – Department of Food Hygiene and Technology and Institute of Food Science and Technology, Thomas Bayeux, Eve Feinblatt, Moez Sanaa – ANSES University of León, León, Spain and ANSES Working Group on Consumer Information on Avelino Alvarez-Ordóñez – Department of Food Hygiene Foodborne Biological Risks (Sandrine Blanchemanche, and Technology and Institute of Food Science and Jean-Christophe Augustin, Laure Bonnaud, Olivier Cerf, Technology, University of León, León, Spain Michel Gautier, Françoise Gauchard, Laurent Guillier, Nathalie Jourdan-Da-Silva, Thierry Meyer, Lydiane Nabec, Louis-Georges Soler, Isabelle Villena) The prevalence of antimicrobial resistance (AMR) in medically significant bacteria is of increasing Almost one-third of foodborne outbreaks reported in concern in the medical and wider scientific France occur at home. Some of these outbreaks are community. The challenge posed by AMR must be related to improper food handling and preparation met on a number of fronts, including restriction practices. Consumer information are needed to raise on the use of antibiotics in animals and humans, awareness of the foodborne diseases that may occur research into new antibiotics and understanding at home and on the measures that consumers can the mechanisms and transmission of resistance. For take to prevent them. In this context, ANSES was the first, it is important that the public are informed requested by the French food safety competence of the issues surrounding AMR, as informed choice authority to provide a scientific opinion on the and appropriate use of antibiotics are responsibilities health and socioeconomic impact of different of individual patients as well as the prescribing communication strategies aimed at consumers. doctors. To determine the level of knowledge about antibiotics and the practices adopted by private The collective expertise was conducted by a individuals in Greece, a survey questionnaire was multidisciplinary working group including experts developed and distributed as widely as possible in social sciences, biological hazards and risk via consumer organisations, professional bodies, assessment. The working group addressed the educational establishments and social media. request in two steps: The survey questions were designed to obtain the 1. The identification of the hazard/food combinations following information: (1) demographic information; that pose the greatest risk and for which preventive (2) antibiotic consumption and practice when taking measures can be applied by consumers, as well as antibiotics; (3) knowledge of general antibiotic use and an inventory of relevant communication strategies. regulation; (4) sources of information on antibiotics; (Opinion of 9 May 2014_ https://www.anses.fr/en/ (5) effect of knowledge of AMR on personal practice system/files/BIORISK2012sa0118EN.pdf ) and choices; and (6) perception of the risk posed by AMR. Analysis of the data gathered by the 2. The evaluation of the effectiveness of survey will identify specific needs and omissions in communication strategies on foodborne risk the information provided to the public about the reduction (Opinion of 14 October 2015_ https://www. dangers associated with AMR and will facilitate the anses.fr/en/system/files/BIORISK2012sa0118Ra-02EN. more responsible use of antibiotics by consumers. pdf), focusing on: The identification of conditions and criteria of effectiveness for communication strategies on the 130. Applying the World Café method prevention of biological risks. to engage pregnant women in food risk The quantitative assessment of the health impact communication of a communication campaign on food handling (three case studies: VTEC/minced meat, Listeria MASCARELLO Giulia monocytogenes/RTE food, Campylobacter/poultry Istituto Zooprofilattico Sperimentale delle Venezie meat). Stefania Crovato, Silvia MarcolinAnna Pinto, Istituto The assessment of cost–effectiveness of Zooprofilattico Sperimentale delle Venezie; communication campaigns (three case studies). Licia Ravarotto – Istituto Zooprofilattico Sperimentale delle This work led to a prioritisation of various Venezie communication strategies in the area of prevention The project piloted a participatory communication of food microbiological risks, taking into account the method designed to share knowledge on food risks targeted populations, the complexity of the message during pregnancy and to frame communication and the cost–effectiveness of the campaign.

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content to be disseminated among pregnant through exposure. The simple transfer of knowledge, women. This group is considered to be more exposed in fact, is not enough for changing habits. It is so to microbiological food risks and more vulnerable mandatory to define new effective strategies for to contracting foodborne diseases that could be nutrition education based on practical activities and dangerous for the fetus. Therefore, it is essential to improved engagement strategies. debunk the misinformation on food safety and provide ‘MaestraNatura’ is an innovative nutrition education pregnant women with reliable information. programme started from 2012 in six Italian regions Pregnant women were engaged through the World involving about 100 schools, 1,000 teachers and Café method, which focus on the dialogue among 20,000 students (aged 6–13) and their parents. The participants that stimulate self narratives and foster aim was to fill the gaps in children’s knowledge informal communication on practical issues related on nutritional issues overcoming possible gender to daily life. The narrative approach was used as differences. an investigation tool to understand behaviours The didactical contents on food, food origin and and perception of risk in the involved group and processing, food safety and questionnaires about as a learning tool, which allowed the analysis of dietary habits were distributed by a web platform. experiences and the generation of new knowledge. To check the transfer of the theoretical information During the World Café, participants discussed contained in the food pyramid into practice, at the on selected topics in small groups around the beginning and at the end of the didactical path, café tables and moved to a new table at regular students were asked to organise daily menus for one intervals, so conversations were cross-fertilised with week. The menus were scored allowing the statistical the ideas generated in former dialogue with other analysis of the results. Girls scored significantly participants. At the end of the process, the main higher than boys (T0 F1,532 = 9.20 P = 0.0025). This ideas were summarised and discussed in a plenary difference disappeared at the end of the didactic session with the involvement of scientific experts path (T1 F1,471 = 2.96 P = 0.0861), supporting the (microbiology, nutrition, gynaecology and infectious efficacy of the contribution. ‘MaestraNatura’ diseases specialists) who answered women’s questions programme might represent a useful new tool for with information on how to prevent food risks. carrying out education intervention on nutrition and food safety among children, to reduce the gaps in The results of the World Café were used to select knowledge and the gender influences on dietary concise communication contents based on choices. perceptions, behaviours and fact-finding needs of the target. These qualitative data were integrated with quantitative ones coming from an online national survey with a sample of both pregnant and 132. Transferring food safety knowledge non-pregnant women. The two groups’ perception from university to society in Indonesia: and knowledge were investigated to identify any challenges and opportunities differences in their level of food risks awareness. As a result, a website (www.alimentigravidanza. MUHAMMAD Dimas Rahadian Aji it) and multilingual brochures were created and Universitas Sebelas Maret disseminated to promote correct food practices during pregnancy. Gusti Fauza – Universitas Sebelas Maret The foremost common problem in the farmer or the small-scale food industry level in Indonesia is the 131. MaestraNatura: education lack of knowledge on good handling/manufacturing programme to promote healthy nutrition process and the food safety aspect. A university habits and food safety in schools is an appropriate agent to overcome this issue as community service is one of the main duties of a university in Indonesia. Moreover, a university plays MASELLA Roberta an important role in the development of science in Istituto Superiore di Sanità a particular area. The Department of Food Science, Beatrice Scazzocchio, Rosaria Varì, Annalisa Silenzi, Universitas Sebelas Maret regularly organises Claudio Giovannini, Antonio D’Amore – Centre for Gender- science and technology transfer to society, targeting specific Medicine, Istituto Superiore di Sanità the farmer or small-scale food industry through community service activity. This activity has been Promoting healthy diet, mainly in youth, is the most successfully carried out in many regions in Java, effective action to prevent and fight dietary excesses Indonesia with the main sponsor being the Ministry and nutrition imbalance in the population. Gender- of Research Technology and Higher Education of related factors influencing lifestyle and exposition the Republic of Indonesia. To achieve the objective to risk factors seem to play major roles in the rising of European Union development, knowledge prevalence of obesity. Recent data show lower transfer from university to society was carried out by percentages of obese/overweight girls than boys in consecutive steps: (1) introduction of good handling/ primary school. Girls consume less sugar-sweetened manufacturing processes; (2) comprehensive beverages and more fruit/vegetables. Food training on food quality management systems; acceptance is a learned process that occurs through and (3) developing entrepreneurship skills. experiences. Children become familiar with food Implementation of food quality and food safety

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management systems will certainly bring were influenced. The information gathered will advantages for both the food producer and the help to develop new strategies and policy agenda consumer. However, in fact, the small-scale food in risk communication at the European level, while industry might rule out the food safety aspect. increasing awareness in the use of antimicrobials This is because this aspect is also ignored by their among consumers. potential consumer. Therefore, food safety education for both the producer and the consumer sides is highly important. We found that promoting food 134. We-Lab & We-Map: a School-Based safety in small-scale industry should be carried out by considering the characteristics and the local Environmental Service Learning project. knowledge of the society to ensure the success of A virtuous model for bringing together food safety campaigns. educational stakeholders

RACCHETTI Erica 133. Lessons learned from a pan- Department of Chemistry, Life Sciences and European questionnaire on consumers’ Environmental Sustainability, University of Parma awareness and risk perception Alessandro Zaccarelli, Alessandro Candiani, Alessandro of antimicrobial resistance Tonelli, Matteo Barozzi – DNAPhone srl Stefano Selleri – Department of Engineering and Architecture, University of Parma; ONICIUC Elena-Alexandra Dunarea de Jos University of Galati Marco Bartoli – Department of Chemistry, Life Sciences and Environmental Sustainability, University of Parma Eleni Likotrafiti – Department of Food Technology, Laboratory of Food Microbiology, Alexander Technological We-Lab & We-Map is a science-based educational Educational Institute of Thessaloniki, Thessaloniki, Greece project developed through a collaborative process Miguel Prieto – Department of Food Hygiene and among different stakeholders of the educational Technology and Institute of Food Science and Technology, systems. The 2-years project involves: University of León, León, Spain Students from 35 schools of the province of Parma Avelino Alvarez-Ordóñez – Department of Food Hygiene (Italy), scattered in the Parma River watershed. Each and Technology and Institute of Food Science and Technology, University of León, León, Spain school has adopted an aquatic environment (canal, river, small lake or well) where nitrate concentration Antimicrobial resistance (AMR) and its impact on is measured using the educational platform We-Lab human health is of great concern and requires and an analytical method. Students monitor, analyse urgent attention. Awareness of this topic among and map a key critical compound for the quality the general population in Europe varies depending of water, strongly affected by land use, agriculture, on country of origin and on the availability of animal farming and wastewater. They disseminate specialised information via different means. A results through the creation of an open data map questionnaire-based study has been developed and public events for the local community. aimed at contributing, at a European level, to the The University of Parma (Department of Chemistry, overall awareness and the risk perceived by the Life Sciences and Environmental Sustainability) general population with respect to the transmission provides: of antibiotic-resistant bacteria from farmed animals and associated foodstuffs to humans. Consumers a method for on-site nitrate analysis, affordable, of different age groups (age 12–17; 18–34; 35–54; robust, safe to handle for students and usable with 55–74 and 75 years or older), different educational We-Lab; backgrounds, who might or might not be related scientific contents (cause–effect relationship to the health or food safety sectors, from different altering the global N-cycle and environmental regions and areas of living, and with varied diets and consequences); household composition were invited to participate in the survey. An online survey as well as written training to teachers and students. forms of the survey were distributed to participants. A local Small-Medium Enterprise (SME): DNAPhone The socio-demographic questions were designed srl provided We-Lab, the technological and to determine which factors may influence a educational platform employed for sample analysis respondent’s answer or opinion. Each respondent and laboratory activities. was asked to complete the questionnaire by selecting the options that felt most appropriate for Some local no-profit organisations active at cultural them. The main objectives of the questionnaire were and social level focused on youth intervention focused on gathering information regarding the (Distretto cinema Parma, Gruppo Scuola risk perceived on human health. More specifically, Cooperativa Sociale and On/Off co-working space) awareness of antimicrobial use, development that produce multimedia documentation. of resistances, and the presence and risk of A local banking foundation (Fondazione Cariparma), transmission of antibiotic-resistant bacteria to which has provided financial support. consumers via food and other reservoirs, were evaluated and the answers provided exhibited the We-Lab & We-Map represents an example of local channels through which consumers’ perceptions action in wich stakeholders cooperate to promote

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and disseminate scientific culture through the Academy of Nutrition and Dietetics, 113(1), 14; primary role of local schools. We-Lab & We- Map [3] Nan, X., Verrill, L., & Kim, J. (2017). Mapping Sources of Food make students aware of concepts such as ecological Safety Information for US Consumers: Findings From a National footprint, sustainability and environmental Survey. Health communication, 32(3), 356–365; monitoring. All stakeholders had the possibility to [4] Schroeder, T. C., Tonsor, G. T., Pennings, J. M., & Mintert, J. (2007). Consumer food safety risk perceptions and attitudes: experiment on: innovative education approaches impacts on beef consumption across countries. The BE Journal such as service learning and STEAM; citizen science; of Economic Analysis & Policy, 7(1), 1–27. environmental and digital literacy; community engagement; and open data creation and access. We-Lab & We-Map has been awarded with ‘Special mention’ by the MIUR. It could represent a ‘model 136. Risk communication strategies approach’ adaptable in multiple contexts and to support public participation subjects and repeatable over larger areas such as in the GMO decision-making process the Po River Basin, a leading European area for food production provinces. ROSADO HUAYNASI Ayrton Andre International Centre for Genetic Engineering and Biotechnology (ICGEB)

135. Eliciting consumers’ preferences Michael Wach – Michael Wach Consulting, Oregon, USA for risk communication strategies: Wendy Craig – Biosafety Group, International Centre for a discrete choice experiment Genetic Engineering and Biotechnology (ICGEB), Trieste, Italy

Most countries provide for public input in the RADU Madalina decision-making process on the use of Genetically University of Stirling Modified Organisms (GMOs). As a result, countries have developed and/or adopted risk communication The communication of food safety and risk strategies to support the active participation of information to consumers plays an important role in the public. Such strategies not only facilitate the public health policies. Studying how best to design exchange of information and opinions on risk factors effective communication strategies has been central by regulators and decision-makers with the public to the policy makers. and other stakeholders, but also help build trust A considerable amount of literature has investigated in the resulting decision. In the developing world, how effective public communication strategies however, most countries have yet to establish viable should be [1–4]. These studies showed that, when mechanisms for such public participation, therefore designing communication strategies, it is critical to their knowledge of the GMO decision-making consider consumers’ risk perceptions, risk attitudes, process and their potential role in it has been intentions and behaviours. However, most of the limited. In recent years, the International Centre for previous food safety interventions highlighted Genetic Engineering and Biotechnology (ICGEB) has that risk communication strategies were designed provided risk communication training to a number around the findings of technical risk assessments of beneficiary countries, in which mechanisms and without addressing factors that might influence procedures to involve the public in GMO decision- consumers’ risk perceptions. Some of these factors making have been discussed and developed. include consumers’ preferences for how to be This review describes key risk communication informed about risks, their understanding of risks strategies comprising the description of standard and consequences of not mitigating such risks. administrative arrangements and examples of communication tools to enable public participation This study investigates consumers’ preferences during the lodgement of GMO applications, for communication campaigns regarding food processing of said applications and for making final safety risks and issues and how preferences vary decisions. Adopting these strategies into national with consumer characteristics and their food risk biosafety regulatory systems may assist developing knowledge and perceptions. The data used for this countries in the establishment of transparent, research were collected via a web-based discrete effective and reliable GMO decision-making. choice survey. Employing probabilistic choice Key words: biosafety, GMO decision-making process, public models, we analysed consumers’ preferences, participation, risk communication perceptions, food safety attitudes and decision- making processes. The results showed the heterogeneity in consumers’ preferences and highlighted the need for designing targeted 137. Social representations of food communication strategies for effective health and risk in the public sphere outcomes. References RUBIN Andrea [1] Fischhoff, B. (2009). Risk perception and communication. Catholic University of Sacred Heart of Milano Oxford textbook of public health, Volume 2: the methods of public health, Ed. 5, 940–953; Recently, nutrition has been linked to many [2] Hornick, B. A., Childs, N. M., Edge, M. S., Kapsak, W. R., interests: social, economical, industrial, commercial, Dooher, C., & White, C. (2013). Is it time to rethink nutrition communications? A 5-year retrospective of Americans’ political but also scientific. These are significant attitudes toward food, nutrition and health. Journal of the issues that concern public opinion and attract

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media attention. In a society that revolves strongly US$30.4 bn. (2010) to US$39.9 bn. (2016) – in the around the media, it becomes relevant to observe global retail market. how public discourse on themes such as food and Drawing upon theories from communication and nutrition is being shaped among the public sphere. public trust in science, we unpack this paradox by In addition, the rise of several techno-scientific analysing GMC and probiotics-related narratives over projects that concern the field of nutrition cannot the past decade from Twitter, Facebook, Instagram help but suggest that nutrition is scrutenised, and food blogs. Our investigation seeks answers to together with its symbolism, like a privileged object the following questions: through which one can also observe the existing ties between science, technology and society. This RQ1) How have consumer sentiments and emotions study started by exploring the characteristics of the associated with GMC and probiotics shifted over the narrative of food themes and their presence in the past decade? public arena through an analysis of the main Italian RQ2) Which key stakeholders or events have daily newspapers. One former longitudinal analysis markedly influenced the direction of social media in the time-span 1992–2013, found – through an sentiment? innovative tool of textual analysis (topic detection) – the presence of some emerging themes. Next, RQ3) Which are the key demographic and we shifted our attention to the later period interest groups engaged in relevant social media (2010–2016), with the aim to focus on most recent conversations? events and to verify whether media discourse on RQ 4) In what ways do these patterns differ between food and nutrition had gained new relevance or the USA, UK and Singapore? forms within the media agenda and in the public discussion. Furthermore, I wished to test the ‘Mazur’s The findings of this study will be used to inform hypothesis’, and sought to identify a relationship public engagement strategies around food policy, between media coverage and the attitudes of the marketing and consumer safety. public opinion by adopting a ‘risk indicator’ and the data from certain European surveys. Biological hazards

138. Social media responses to probiotics and GM foods – a chronological 139. The overview of a Trichinella and cross-cultural analysis outbreak in Cajetina, Serbia, 2016

VIJAYKUMAR Santosh ANDRIC Aleksandra Northumbria University Institute of Public Health, Uzice, Serbia

Kristofor McCarty, Cuthbert Mutumbwa – Northumbria Marija Baralic – Institute of Public Health, Uzice University Dragana Dimitrijevic – Institute of Public Health, Beograd Claudia Pagliari – University of Edinburgh Background: Trichinellosis is a disease caused by Technological advances in the food industry during Trichinella, which belong to the group of zoonoses. the 21st century have been accompanied by the rise A trichinellosis disease outbreak in Cajetina was of social media as a channel of communication and discovered on 22 January 2016 when a hunter influence. This has led to new challenges for a sector from Cajetina was hospitalised at the infectious in which the successful translation of innovations department of the General Hospital in Uzice is highly dependent on public attitudes. Such under suspicion of trichinellosis. The patient had attitudes are also shaped by the socio-political and consumed dried wild boar meat in late December cultural context in which science takes place. 2016. During the outbreak, 300 people consumed We investigate these co-dependencies by infected meat, sausages and ham from two wild chronicling the evolution of consumer sentiments boars and a deer. on social media related to two food innovations: Methods: For the analysis of the outbreak, the genetically modified (GM) foods and probiotics. descriptive epidemiological method was applied. While both derive from advances in biotechnology, We described the basic clinical and epidemiological public responses to them have been markedly characteristics of the patients as well as the different. most important results of the epidemiological– Even though GM foods have been endorsed by epizootiological research of this outbreak. The survey the scientific community for safety and global instrument was an epidemiological questionnaire. sustainability, demand for products labelled ‘non- Results: In Uzice General Hospital, since the GMO’ have spiralled from $12.9 bn. (2012) to $21.1 detection of the outbreak, 273 people had been bn (2016), reflecting widespread public scepticism. examined and 120 of them were reported as Contrastingly, public confidence in probiotics infected. In Uzice General Hospital there were 19 products continues largely unhindered despite hospitalised patients (14 adults and 5 children). inconclusive scientific evidence surrounding the The mean age of the patients was 32.3 years, health efficacy of these products. This is illustrated ranging from 3 to 64 years. Male to female ratio in the growth of the probiotics segment – from

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of cases was 1.75:1. The diagnosis was based on 141. Risk assessment of Listeria the epidemiological data, clinical and laboratory monocytogenes in dry-cured ham: a tool findings. Trichinella britovi was identified using to assess the compliance with the Listeria multiplex PCR at the National Laboratory for parasites. zero policy.

Conclusions: The way of transmission in this BOVER-CID Sara outbreak was eating sausages and hams originating IRTA from wild pork infected by Trichinella britovi. Trichinoscopic examination (digestion method) of S Bover-Cid, A Jofré, C Serra-Castelló, MI Garriga – each slaughtered boar’s meat and the underlying RTA (Institute of Agriculture and Food Research and thermal processing of meat and meat products Technology) prevents the infection. For the prevention of similar outbreaks, it is highly important to improve The present study aimed to develop a QMRA model knowledge of people working on the preparation of Listeria monocytogenes in dry-cured ham. The food about the risk of foodborne diseases. study included the modelling of the behaviour of L. monocytogenes in Serrano and Iberian dry-cured ham as a function of the water activity (aw) and 140. Monitoring of resistance genes storage temperature through challenge testing. in Listeria monocytogenes isolates and their Sliced ham was inoculated at ca. 6 log cfu/g with a presence in extracellular DNA of the biofilm four-strain L. monocytogenes isolate (serotypes 1/2a, 1/2b, 1/2c and 4b), vacuum packaged and stored at 2, 8, 15 and 25°C for up to 6 months. The pathogen BOHACOVA Martina was periodically enumerated on Chromogenic UCT Prague Listeria Agar. The Weibull model was used to Kamila Zdenkova – consultant estimate inactivation kinetic parameters. The impact Viviana, Fuchsova – helping student of temperature and aw was modelled using a polynomial equation. A QMRA model was built from Katerina, Demnerova – head of the laboratory data distributions obtained from manufacturers, Jarmila Pazlarova – supervisor regarding initial pathogen concentration, aw and storage time/temperature. The alarming occurrence of antibiotic resistance genes in food production demands continuous Dry-cured ham did not favour the growth of the monitoring world-wide. One reservoir of resistance pathogen but exerts a temperature – and aw- genes is thought to be eDNA. There is currently dependent bactericidal effect, suggesting the little available information in Europe about either potential interest of designing risk minimisation the extracellular DNA distribution of the bacterium strategies based on the non-thermal inactivation in or the spread of resistance genes. Therefore, our the final product. aim was to give insight into the L. monocytogenes According to the developed QMRA model, the resistance situation in the Czech Republic and estimated probability of listeriosis due to the assess the presence of resistance genes in their consumption of dry-cured ham is very low (in the extracellular DNA (eDNA). First, susceptibility tests order of 1·EXP-14 and 1·EXP-12 cases/serving for were performed on 49 isolates of L. monocytogenes healthy and susceptible population, respectively), with selected antibiotics. Next, we tested the corresponding to the ‘Very Low Risk’ cluster of foods DNA of suspected isolates for the presence of established by the risk assessment published by resistance genes in both planktonic cells and FDA/USDA in 2003. However, from the industrial the eDNA of biofilms. Finally, fluorescence confocal sector point of view and regarding the compliance microscopy was used to observe the eDNA of regulations derived from the zero tolerance policy pattern of selected isolates under conditions that for L. monocytogenes, the concern is related to the mimicked the food processing environment and non-negligible probability that the pathogen is the human body. Susceptibility tests found isolates present at detectable levels. To minimise this risk, with intermediate resistant to chloramphenicol, producers can assess the application of different tetracycline and ciprofloxacin as well as isolates strategies either focused on the minimisation of the resistant to ciprofloxacin. For all suspected isolates, contamination or the application of post-lethality PCR confirmed the presence of the gene lde treatments. encoding an efflux pump in both types of DNA. The presence of an efflux pump in both types of DNA suggests that the eDNA might serve as a reservoir of resistance genes. Our results suggest that the current risk of the spread of L. monocytogenes resistance genes is low in the Czech Republic, but they also indicate the need for continuous long-term monitoring of the situation.

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142. A semi-quantitative model processing. The possibility for bacterial cells to for ranking the risk of incursion of exotic adapt to the stress, increasing their resistance, animal pathogens into Europe has been reported by several authors (e.g. Hill et al., 2002; Richter et al., 2010). This adaptation may be developed because of a short sublethal stress CONDOLEO Roberto (such as a heat shock) or during a dynamic heat Istituto Zooprofilattico Sperimentale del Lazio e Toscana treatment, if it starts with a slow heating phase. Robin Simons, Verity Horigan – Animal and Plant Health A mathematical model was recently developed to Agency describe such a situation (Garre et al., 2018). This Helen Roberts – DEFRA model allows the clear differentiation between the static thermal resistance (the one due to Several risk ranking methods have been developed the instantaneous temperature without taking to prioritise the impact of exotic animal diseases in into account the heating history of the cells) and a specific EU MS country/area (i.e. effects on animal stress adaptation. It has been used to describe the health, welfare or trade consequences). Such tools inactivation of two different strains of Escherichia are used to assist risk managers in optimising the coli (K12 MG1655 and CECT 515) during mild allocation of available resources for the prevention dynamic inactivation treatments. The results of this and control of infectious diseases. However, few investigation show that, although strain K12 MG1655 models focus on prioritisation methods on the has a higher resistance to isothermal treatments, probability of entry of an exotic pathogen into a strain CECT 515 is able to adapt better to the thermal territory (Roberts, 2011). To fill this gap, we have stress. As a consequence, strain CECT 515 is more developed a multicriteria model to estimate the resistant for thermal treatments allowing for the probability of incursion of an exotic pathogen into development of stress adaptation. a European country. The tool uses a score system method and it has been developed using Italy as a This result is especially relevant for microbiological case study. A selection approach, taken from the EU risk assessment, in which the calculations are usually SPARE project (using Shiny app), has been applied limited to a handful of bacterial cells considered to produce a list of infectious diseases that are non- as the most resistant. This selection is usually endemic in Italy and subject to OIE notification. We performed according to the bacterial resistance to divided the world into different areas and used OIE isothermal treatments; i.e. without any consideration data to allocate to them a ‘disease status’ for each for the stress adaptation. The results of this of the selected diseases (i.e. endemic, absent…). investigation show that this criterion may lead to the Then, we identified several possible pathways for a selection of bacterial strains which are not the most pathogen introduction (i.e. animal trade, vectors…) resistant to the particular treatment considered. and we defined the relevant factors for each specific References pathogen. Import trade data regarding animal Garre, A., Huertas, J. P., González-Tejedor, G. A., Fernández, P. S., and animal products were collected to estimate Egea, J. A., Palop, A., et al. (2018). Mathematical quantification of the potential likelihood of entry of the different the induced stress resistance of microbial populations during pathogens through an associated commodity as non-isothermal stresses. Int. J. Food Microbiol. 266, 133–141. well as information about people and wild animal doi:10.1016/j.ijfoodmicro.2017.11.023. movements which can be routes of introduction of Hill, C., Cotter, P. D., Sleator, R. D., and Gahan, C. G. M. (2002). Bacterial stress response in Listeria monocytogenes: jumping some pathogens. Finally, an algorithm is proposed the hurdles imposed by minimal processing. Int. Dairy J. 12, to calculate an overall risk score for each pathogen. 273–283. doi:10.1016/S0958–6946(01)00125-X. The results can be used by official authorities to Richter, K., Haslbeck, M., and Buchner, J. (2010). The Heat Shock strengthen the border surveillance towards those Response: Life on the Verge of Death. Mol. Cell 40, 253–266. pathogens with higher probabilities of entry. doi:10.1016/j.molcel.2010.10.006.

143. The relevance of stress adaptation 144. Microbial quality and safety of raw for risk assessment. Comparison of the edible house crickets (Acheta domesticus) resistance of two bacterial strains to survive dynamic thermal treatments FERNANDEZ-CASSI Xavier Department of Biomedical Sciences and Veterinary Public Health, Swedish University of Agricultural Sciences, EGEA Jose A. Uppsala, Sweden Technical University of Cartagena Karin Söderqvist – Department of Biomedical Sciences Alberto Garre, Asunción Iguaz, Alfredo Palop, Pablo S and Veterinary Public Health, Swedish University of Fernandez – Departamento de Ingeniería de Alimentos Agricultural Sciences, Uppsala, Sweden y del Equipamiento Agrícola, Instituto de Biotecnología Vegetal, Universidad Politécnica de Cartagena Alexandru Supeanu – Directorate for Animal Health, National Sanitary Veterinary and Food Safety Authority in Quantitative microbial risk assessment relies on Romania, Bucharest, Romania an accurate description of the bacterial response Anna Jansson – Department of Anatomy, Physiology and to the environmental conditions during the farm- Biochemistry, Swedish University of Agricultural Sciences, to-fork cycle of the food product. This includes the Uppsala, Sweden modelling of the microbial inactivation during Sofia Boqvist – Department of Biomedical Sciences and

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Veterinary Public Health, Swedish University of Agricultural 145. Comparison of different multicriteria Sciences, Uppsala, Sweden decision analysis algorithms for Merko Vaga – Department of Anatomy, Physiology and Biochemistry, Swedish University of Agricultural Sciences prioritising emerging zoonoses Ivar Vågsholm – Department of Biomedical Sciences and Veterinary Public Health, Swedish University of Agricultural GARRE Alberto Sciences, Uppsala, Sweden Universidad Politécnica de Cartagena

Entomophagy is a growing in western countries Géraldine Boué– SECALIM, INRA, Oniris, Université where insects have not been traditionally used as Bretagne Loire, 44307, Nantes, France food. Since January 2018, edible insects are regulated Jose A Egea – Departamento de Matemática Aplicada y under the novel foods Regulation (EU) 2015/2283. Estadística, Universidad Politécnica de Cartagena Despite their inclusion as novel foods, there is a lack Pablo S Fernandez– Departamento de Ingeniería de of EU hygiene legislation regarding edible insects. Alimentos y del Equipamiento Agrícola, Instituto de However, a few EU countries such as Belgium and Biotecnología Vegetal, Universidad Politécnica de the Netherlands have presented specific microbial Cartagena hygiene criteria recommendations. This lack of Jean-Marie Membré – SECALIM, INRA, Oniris, Université common regulatory framework within Europe is Bretagne Loire, 44307, Nantes, France explained by the lack of data available regarding Decision-making in food safety is a complex microbial loads in edible insects. Comparative process, which involves several factors of different evidence might be derived from studies of insects nature such as the expected reduction in the belonging to different species or reared under number of illnesses, the potential economic cost, completely different conditions (e.g. field-collected the environmental impact or others. Multi Criteria insects). Moreover, insect’s biodiversity is huge with Decision Analysis (MCDA) algorithms have been species estimations ranging from 2.6 to 7.8 million developed to help decision-making process and reinforcing the idea that microbial criteria for by ranking different options in a multifactorial one species should not be presumed suitable for environment. Initially, MCDA algorithms only allowed another species. to rank the different options using the expected House cricket (Acheta domesticus), previously used value of the factors considered. However, uncertainty as pet food, represents one of the reared insects and variability play an important role in MCDA, with more potential for human consumption. In the especially in microbial risk assessment (Nauta, present study the microbial load and microbiome 2000). So, algorithms have been developed (usually of Acheta domesticus from Sweden that was based on the application of fuzzy sets) to consider feed with eight different feed based on red clover uncertainty and variability in every factor. (Trifolium pratense), will be studied by using culture- The aim of the present work is to investigate which dependent and high-throughput sequencing (HTS) MCDA algorithm might be used to support food approaches. safety decision-making process in a multifactorial To assess the food safety and microbial quality of environment. To undertake this, a dataset published edible crickets, they will be analysed for Salmonella, by Havelaar et al. (2010) ranking emerging zoonoses Listeria monocytogenes (qualitative methods), in the Netherlands according to various criteria Clostridium perfringens, Total Aerobic Counts (TAC), (probability of introduction, transmission between Enterobacteriaceae, yeasts and moulds (quantitative animals, economical damage, transmission from methods). Preliminary results on edible raw crickets animals to humans, transmission between humans, showed TAC and Enterobacteriaceae microbial loads morbidity and mortality) is analysed. Havelaar et ranging from 7.9 Log CFU/g and 7.0 Log CFU/g, al. (2010) devised a multicriteria decision analysis respectively. None of the samples were positive for (MCDA) algorithm, able to account for uncertainty Clostridium perfringens (<1.0 Log CFU/g). The high and variability, specifically for this dataset. We observed microbial loads on raw edible crickets compare their results against those obtained using suggests the need of a heat treatment before other algorithms extensively used in the MCDA consumption both to control food pathogens and literature: MMORA, TOPSIS, VIKOR, WASPAS and spoilage flora and extending the shelf life. These ELECTE. All of these algorithms are able to take into findings highlight that specific microbial hygienic account uncertainty and variability, or to perform the criteria for reared crickets should be considered. calculation using expected values. The results show differences between the rankings calculated using each algorithm. The results provided by the WASPAS algorithm are the closest to the ones calculated by Havelaar et al. (2010) (correlation coefficient 0.89), whereas VIKOR presents the highest discrepancies (correlation coefficient 0.55). Furthermore, the relevance that uncertainty and variability have on the ranking is demonstrated.

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146. Real-time PCR development for Anisakis revising health advices given to pregnant women larvae quantification in commercial fish and vulnerable groups on Listeria monocytogenes. To support the revision NFSA requested an assessment from the Norwegian Scientific GODÍNEZ-GONZÁLEZ Carla Committee for Food and Environment (VKM). To Laboratory of Parasitology, Department of Biology, specify their request the NFSA divided it into the Health and Environment, Faculty of Pharmacy and Food four product groups they wanted assessed: fish and Sciences, University of Barcelona, Barcelona, Spain seafood, meat products, cheese/dairy products and Xavier Roca-Geronès, Isabel Montoliu, Roser Fisa – vegetables. All food groups were further divided into Laboratory of Parasitology, Department of Biology, subgroups. Ready-to-eat (RTE) products were not Health and Environment, Faculty of Pharmacy and Food grouped separately, but were to be assessed within Sciences, University of Barcelona, Barcelona, Spain the four product groups.

Through food supply chain, humans are exposed In addition, the Norwegian Food Safety Authority to a variety of foodborne zoonoses, seafood has wanted an assessment of the effect of various been reported to be parasitised by Anisakis in the measures that the consumer can take: storage major part of oceans and seas around the word, at refrigerator temperature <4°C; eating the food which could represent a hazard to consumers early in the shelf life period; avoiding food leftovers due to larvae L3’s ability to cause gastrointestinal kept in the fridge for several days; only eating symptoms and allergic reactions. A SYBR Green small amounts of the food; choosing products with qPCR-based protocol was validated to quantify additives/modified atmosphere that reduce growth the number of Anisakis larvae in commercial fish of Listeria; heating the food before consumption using a mathematic model, avoiding the visual (criteria for good heat treatment); and reducing the inspection. Fillets of hake were verified for Anisakis storage time for leftovers in the refrigerator. absence by visual inspection and qPCR. Samples VKM has prepared a quantitative assessment of of 15 g of Anisakis-free fillets were experimentally exposure to L. monocytogenes from fish, meat contaminated and homogenised with different and cheese/milk products using Food Safety and number of A. simplex (s. l.) L3 larvae. DNA extraction Spoilage Predictor (FSSP), while vegetables were was performed employing the Wizard Genomic assessed qualitatively. DNA Purification Kit. An Anisakis-specific SYBR Green qPCR assay was performed, using a pair of primers previously described which amplify a fragment of the mitochondrial cytochrome c 148. Understanding prophylactic usage oxidase II gene. The results showed a logarithmic of antimicrobials in British sheep flocks behaviour, which allowed to obtain a mathematic at the time of lambing: results from model to estimate the number of larvae in samples a large-scale survey of unknown parasitisation samples using the Cq value of the sample. Furthermore, 42 specimens LIMA Eliana of blue whiting, purchased at the supermarket in University of Nottingham Barcelona, where analysed by visual inspection and using the developed SYBR Green qPCR Charlotte Doidge, Fiona Lovatt, Peers Davies, Jasmeet technique, the correlation analysis revealed the high Kaler – University of Nottingham concordance between both methods (R2 = 0.92). The developed assay is able to ensure the Anisakis The largest annual amount of lamb meat produced absence and to quantify with enough accuracy from in Europe originates from extensive, grass-based one to 35 larvae, including the detection of traces systems located in the United Kingdom. Low record (CV = 3.39%), which avoids false-negative results. The keeping traditionally associated with these farming optimised SYBR Green technique for Anisakis larvae systems was recently brought to attention due to quantification could be used not only in the food the raising concerns on antimicrobial resistance in industry but also for research centres and the public livestock production. Although believed to be lower health prevention programmes, contributing to than in pig and poultry industries, there is currently improve the safety and quality of fish products. little knowledge on antimicrobial usage (AMU) in sheep farming. This study aimed at building evidence on prophylactic usage of antimicrobials during lambing time, which is considered a period 147. Listeria monocytogenes – health advice with higher risk for AMU. for pregnant women and vulnerable groups A survey on farm characteristics, antimicrobial usage and flock productivity was distributed among 740 GRAHEK-OGDEN Danica commercial British sheep farmers during summer Norwegian Scientific Committee for Food and 2016. The Kruskal–Wallis statistical test was used Environment to explore associations between prophylactic Taran Skjerdal, Jan Thomas Rosnes, Georg Kapperud, antimicrobial usage and flock characteristics, and Eystein Skjerve, Judith Narvhus, Jørgen Lassen, Karl a multivariable linear regression model was built Eckner, Truls Nesbakken to analyse the relationship between antimicrobial usage and flock productivity while controlling for The Norwegian Food Safety Authority (NFSA) confounders. provides health advice to different groups and is

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More than one-third of the surveyed farmers (35%, Nevertheless the following clause refers to available 259/740) administered spectinomycin orally and information. Interpretation Article 14 could be prophylactically to new-born lambs, and 7% (32/431) reconsidered, but further education of the consumer administered amoxicillin or penicillin parenterally. has to be encouraged for this increasing trend. Using antibiotics prophylactically did not provide an Pathogens and the education of consumers will stay additional advantage in relation to flock productivity relevant in our changing world. (no significant association between prophylactic antimicrobials usage and flock production in multivariable analysis (P ≥ 0.05)). Farms where lambs 150. First comprehensive study on West Nile were administered antibiotics prophylactically had a significantly lower median flock size than farms not in Former Yugoslav Republic of the former providing them (470 and 616 ewes, respectively (P ≤ Yugoslav Republic of Macedonia (FYROM) 0.05)). No association was found between farm region and prophylactic use of antibiotics during lambing. MESHTEROVIKJ Srgjan Food and Veterinary Agency, Skopje These results suggest that prophylactic usage of oral antimicrobials in neonatal lambs is relatively Srgjan Meshterovikj, Food and Veterinary Agency common and that smaller flocks have a significantly Paolo Pasquali, Istituto Superiore di Sanità, Rome greater prophylactic AMU. Importantly, the products Jovana Stefanovska, Aleksandar Cvetkovikj, Kiril Krstevski, used are not are not classified as critically important Igor Djadjovski – Department of Parasitology and antimicrobials. Promotion of alternative disease Parasitic Diseases, Faculty of Veterinary, Skopje prevention practices such as better hygiene and Gordana Kuzmanovska – Institute of Public Health, Skopje vaccination may aid lowering AMU in sheep flocks. Nikolina Sokolovska – PHO Centre for Public Health, Skopje Francesca Barchiesi, Stefano Gavaudan, Giorgia Angeloni – Istituto Zooprofilattico Sperimentale dell’Umbria e delle 149. Raw milk in vending machines – Marche, Perugia results Austria 2017 In the last decade recurrent outbreaks of West Nile Disease were reported in humans and animals in MATT Monika Balkan areas, including FYROM. To investigate virus AGES spread in this last, during 2017 a comprehensive study (aimed to define the risk assessment for WNV In Austria an increasing trend for organic products in FYROM) was conducted by IZS dell’Umbria e delle and purchase of raw products from local producers Marche in collaboration with the Institute of Public is recognised. Raw milk is sold on farm, by vending Health, Faculty of Veterinary Medicine and Food and machines or delivered locally. Most of the consumers Veterinary Agency, that have provided all WNV data lack of fundamental knowledge on pathogens and available in the country. The study was performed do not link them to raw milk. Supplementary to EU in the contest of the EU twinning project ‘Further regulations (No. 178/2002, etc.) the ‘national raw milk development of competent authorities control systems regulation’ dictates a clear warning ‘raw milk, to be boiled to protect the human, animal and plant health’. before consumption’ on the vending machine or in the On the basis of data provided from IPH, from 2011 salesroom. Additionally the aerobic mesophilic total plate to 2017, 22 human cases of WND were notified in count (TPC) of 50,000 CFU/ml must not be exceeded. FYROM the majority of which (81.8%) without a Samples with detected pathogens are deemed as recent story of travel abroad; 50% of cases showed ‘injurious to health’ only if no warning is in place. neurological signs and three patients died (all in Official controls of 74 vending machines were 2012). No systematic information about WNV lineages performed in July/August 2017. TPC, identification are available, although lineage 2 is the most probable. of pathogens (VTEC, Campylobacter, Salmonella, Regarding WNV surveillance in animals, during Listeria) and detection of quaternary ammonium 2011–2012 an active sero-surveillance plan was cations (Quats) have been performed. Additionally implemented in domestic birds highlighting viral specific attention was given to labelling and circulation also in animals with 5.6% and 3.2% of birds warnings at the vending machine. and horses tested positive for IgG Ab. All analysis Conformity assessment indicated accordance to all were performed in the laboratory of the FVM. regulations for 38 vending machines, including their Finally, the mosquito population in the country raw milk samples. The TPC of 22 samples (29.7%) was investigated using both adults traps (CDC exceeded 50,000 CFU/ml, with a maximum of 1.8 × 7 light traps BG sentinels), ovitraps and larval stages 10 CFU/ml. Salmonella dublin and Campylobacter captures confirming the presence of Culex pipiens, jejuni have been detected once whereas two the main vector of WNV. Serendipitously, presence samples contained Verotoxin producing E. coli. No of adult Aedes albopictus was confirmed for the first Listeria could be isolated. In two samples the limit of time in FYROM raising a lot of concern due to his detection was exceeded for Quats. competence for many viral diseases. The General Food Law indicates whether any food In conclusion, due to wide circulation of WNV in is unsafe, the normal conditions of use by the the country in the presence of a competent vector, consumers should be regarded – which might a systematic surveillance plan involving birds and be the consumption of raw milk as raw milk. equids is strongly suggested.

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151. A predictive model for survival strains, to reproduce the domestic process at of Escherichia coli O157:H7 in manure- industrial level. Before commercialisation, the amended soil definition of risk points was fundamental and the set-up of microbial challenge test to define the safety aspects associated to this new fermented MOKHTARI Amir product was necessary. Given its characteristics, the FDA major risk could be associated with the presence Hao Pang, Yuhuan Chen, David Oryang, David Ingram, of Enterobacteriaceae (in particular, Escherichia Jane Van Doren – FDA coli) and Listeria monocytogenes. Therefore, these pathogens were deliberately inoculated in the Untreated biological soil amendments of animal nuts at the beginning of the process together origin (BSAAO), such as raw bovine manure and with different mixtures of autochthonous or poultry litter, are known reservoirs for enteric commercial LAB starters. The results showed that pathogens such as Escherichia coli O157:H7 and the fermentation could contribute to inhibit E. coli Salmonella. Once introduced into the soil through and L. monocytogenes proliferation, depending the application of untreated BSAAO, these pathogens on the LAB starter used. Not all the starters were have been shown to survive and may contaminate able to counteract the pathogens because the fresh fruits and vegetables growing in or near the accumulation of organic acids did not allowed contaminated soil. Characterising the impact of to reach a pH value below 4.4, considered a safe agricultural and environmental factors on survival of threshold for L. monocytogenes (EU Regulation enteric pathogens in untreated BSAAO-amended soil 2073/2005). The use of strains endowed with is an essential part of understanding public health antimicrobial activity resulted in a reduction of L. risks associated with application of untreated BSAAO. monocytogenes cell counts from the earliest phases The aim of this study was to develop a predictive of production. model to characterise the relationship between a This study allowed the set-up of a guided vegan ‘cheese’ variety of agro-ecological factors and changes in fermentation process, where the main biological hazards populations of E. coli O157:H7 in manure-amended were controlled through a proper and rapid acidification soil under dynamic environmental conditions. We (able to inhibit Enterobacteriaceae), combined also developed and validated a Random Forest model with strains exerting antimicrobial activity against L. using data from a longitudinal study investigating monocytogenes. the survival of E. coli O157:H7 in BSAAO-amended soils. Initial inoculation level, days post-inoculation, soil moisture content, and cumulative rainfall since the last sampling day were identified as the most 153. Campylobacter jejuni food isolates influential factors impacting the E. coli O157:H7 harbouring different types of tetracycline concentration in amended soil. The Random Forest resistance model outperformed direct data fitting using classic log-linear and Weibull survival kinetics models when PACÍFICO Cátia observed data showed non-linearity and fluctuations Institute for Meat Hygiene, Meat Technology and Food due to pathogen growth or regrowth. With available Science, University of Veterinary Medicine of Vienna; Karl data, the modelling framework reported here can Landsteiner University of Health Sciences, Dr-Karl-Dorrek- also be adapted for similar enteric pathogens such as Strasse 30, 3500 Krems an der Donau, Austria Salmonella. M Wösten – Department of Infectious Diseases and Immunology, Utrecht University, the Netherlands 152. Safety evaluation of an innovative D Sofka – Institute of Meat Hygiene, Meat Technology and Food Science, University of Veterinary Medicine, fermented nut-based product Veterinaerplatz 1, 1210 Vienna, Austria J Carriço – Instituto de Microbiologia, Instituto de Medicina MONTANARI Chiara Molecular, Faculdade de Medicina, Universidade de Università di Bologna Lisboa, Lisbon, Portugal F Hilbert – Institute of Meat Hygiene, Meat Technology Giulia Tabanelli, Fausto Gardini – CIRI Agroalimentare, and Food Science, University of Veterinary Medicine, Università di Bologna Veterinaerplatz 1, 1210 Vienna, Austria

The set-up of a new food requires the study of the Tetracycline resistance in Campylobacter food biological risks associated to the product and the isolates is quite common. Most Campylobacter implementation of strategies to avoid or reduce isolates harbour tetO, a gene coding for a ribosomal these risks. The present study started from the protection protein. Epidemiological resistance characterisation of a fermented nut-based vegan to tetracycline in Campylobacter is defined by food produced under domestic conditions. Lactic an harmonised epidemiological cut-off value acid bacteria (LAB) responsible for the natural of 1 mg/L in Europe according to EUCAST. Most fermentation process were identified, revealing resistant isolates display resistance to 64–128 mg/L a succession of hetero- and homo-fermentative tetracycline. Here we describe two isolates of C. jejuni species during fermentation. Some autochthonous (named FC77 and FC88) isolated from chicken meat strains isolated from this product were then used, harbouring a functional tetO coding sequence, in combination also with other commercial LAB but expressing tetracycline resistance below the

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epidemiological cut-off value. For detailed analysis, strain was isolated, among others, during a sampling both isolates and a high level tetracycline-resistant campaign in Ria Formosa lagoon (Faro, Portugal). isolate of C. jejuni (GC119) were sequenced by whole- A rapid antimicrobial screening in multiwell plates genome sequencing using Illumina technology. was developed identifying 10 bacteria able to inhibit foodborne pathogenic strains. The most Genome assembly was conducted using the active, named Pseudomonas sp. 8C, was cultivated INNUca pipeline, followed by genome annotation under different conditions, extracted by organic using prokka (v 1.12). Detection of antimicrobial solvents and the obtained extract submitted to resistance and virulence genes was performed using liquid inhibition assay. The results showed a high ABRicate (v 0.8) bundled with CARD, Resfinder, ARG- antimicrobial effect against S. aureus, P. fragi, E. ANNOT, NCBI and VFDB databases. coli, C. jejuni and L. monocytogenes with a Minimal The assembled genomes have between 29 and 36 Inhibitory Concentration range between 20–90 contigs, representing a genome sequence length µg/ml. The promising results of the crude extract between 1.73 and 1.75 Mbp. All isolates have between will lead to further investigation, which will involve 1,791 and 1,814 coding sequences, 40 tRNAs, two the purification, isolation and identification of rRNAs and one mRNA; tetO was identified in all the compounds responsible for this bioactivity. three isolates by the multiple databases used. The This work confirms the great potential of marine Resfinder database showed that the tetO gene of microorganisms in foodborne illness control. isolate GC119 is 99.53% similar to the tetO described for C. jejuni (GenBank: M18896.2), while the tetO of FC77 and FC88 is 99.64% similar to the tetO gene 155. Antimicrobial resistance of broilers of Streptococcus pneumoniae (GenBank: Y07780.1) which harbours a truncated form of the promoter in Bulgaria in 2014 and 2016 region. Nevertheless, there is transcription of the gene in both isolates as detected by RT-PCR. PETLOVA-DASKALOVA Dora Risk Assessment Centre on Food Chain, Ministry of Although using the current epidemiological Agriculture, Food and Forestry cut-off value for C. jejuni these strains would be considered susceptible to tetracycline, the presence Nikolay Cholakov, Teodora Ivanova, Hristo Daskalov* – of a functional gene encoding resistance to this National Centre of Food Safety, NDRVMI, BFSA antibiotic may challenge this definition and appeal *Corresponding author: [email protected] to its reconsideration. Results of the implementation of the Commission Decision on the monitoring and reporting of antimicrobial resistance in zoonotic and commensal 154. Foodborne illness control by using bacteria (2013/652/EU) in broiler production in marine bacteria 2014 and 2016 in Bulgaria are presented. Samples from broiler caeca were collected from single PALMA ESPOSITO Fortunato epidemiological units in all slaughterhouses in Institute of Protein Biochemistry, National Research Bulgaria. The numbers of tested caeca samples Council, 80131 – Naples, Italy in 2014 were 412 and in 2016 were 442. In 2014, 85 commensal Escherichia coli and 110 Campylobacter E Tortorella, GA Vitale, M Pacelli, D de Pascale – Institute of jejuni isolates were tested and reported to EFSA. Protein Biochemistry, National Research Council, 80131 – In 2016, 111 commensal Escherichia coli and 55 Naples, Italy Campylobacter jejuni isolates were tested and Nowadays, a common problem for both developed reported to EFSA. In 2016, all 442 caeca samples and developing countries is represented by were tested for ESBL/AmpC/carbapenemase- foodborne pathogenic bacteria. Among the producing E. coli and 123 of these were positive. High most dangerous include S. aureus, E. coli, Listeria levels of antimicrobial resistance in E.coli isolates monocytogenes, Campylobacter sp., Salmonella against ampicillin (76.6%), tetracycline (68.5%), sp. and to make the situation worse, many strains sulfamethoxazole (79.3%) and cyprofloxacinae (86.5%) become resistant to most of the common antibiotics were detected. A high percentage of multidrug- released on the market. Although a good food resistant isolates were found. In total, 27.8% of safety practice is necessary to prevent the spread caeca samples were positive for ESBL/AmpC/ of foodborne bacteria, new antimicrobials are carbapenemase-producing E. coli. A high level of needed to fight and control this threat. During the resistance of C. jejuni against ciprofloxacin (85.5%) last years, the sustainable exploitation of natural and tetracycline (43.6%) was detected. The data for products derived from marine microorganisms antimicrobial resistance of C. jejuni and E. coli from demonstrated to be a promising strategy to obtain caeca samples are discussed. new bioactive compounds for biotechnological Key words: antimicrobial resistance, Escherichia coli, applications. In this work we showed the strong Campylobacter jejuni, antibiotics antimicrobial activity of an extract produced by a marine bacterium, towards a wide panel of foodborne pathogenic bacteria. A double approach, which include metagenomics and classic isolation techniques, was applied as part of ‘1st EMBRIC Transnational Access programme’. The producer

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156. Intestinal health problems in broilers 157. Understanding swine veterinarians’ in Belgium; risk factors and preventive treatments decisions by unravelling the measurements complexity of the swine health system

RINGENIER Moniek ROJO-GIMENO Cristina University of Ghent Social Sciences Unit, Flanders Research Institute for Agriculture, Fisheries and Food, Burgemeester van Nele Caekebeke, Fien De Meyer, Filip Van Immerseel, Gansberghelaan 115, Box 2, 9820, Merelbeke, Belgium; Jeroen Dewulf – Faculty of Veterinary Medicine, Ghent Department of Reproduction Obstetrics and Herd University Health, Faculty of Veterinary Medicine, Ghent University, Objectives: Intestinal health problems and wet Salisburylaan 133, 9820 Merelbeke, Belgium litter are the main indicators for antimicrobial Jeroen Dewulf, Dominiek Maes – Department of usage (AMU) in the broiler industry. The first goal Reproduction Obstetrics and Herd Health, Faculty of of this project was to determine the prevalence of Veterinary Medicine, Ghent University, Salisburylaan 133, dysbacteriosis (DB) in broilers in Belgium. Followed 9820 Merelbeke, Belgium by the identification of risk factors and protective Wauters Erwin – Social Sciences Unit, Flanders Research factors for the development of DB or aspecific Institute for Agriculture, Fisheries and Food, Burgemeester intestinal health problems. This will lead to a more van Gansberghelaan 115, Box 2, 9820, Merelbeke, Belgium; objective diagnosis and specific treatment of intestinal health problems in broilers. Given the public health threat posed by antimicrobial resistance, voluntary and mandatory Methods: First, 50 broiler farms were randomly policies have been developed to reduce selected. Farm-specific information was collected on antimicrobial usage (AMU). To enforce these, the technical results, AMU and biosecurity. On 10 broilers veterinarian plays a crucial role by providing farm- (age 28 days) necropsy was performed. Macroscopic specific advice. However, there are other private/ lesion scoring for DB (Teirlynck et al., 2011), public people and institutions, all part of the swine coccidiosis, presence of crop filling, hock burns and health system (SHS), that influence the veterinarians’ footpad lesions and collection of intestinal segments advice and treatment decisions. Understanding was executed. Also water, feed and litter samples the functioning of the SHS is crucial to identify were collected. In the second study, 20 farms were incentives and barriers for implementing policies followed during five visits in one production round. to reduce the AMU. To understand the functioning Each visit, necropsy was performed on 10 animals to of the SHS in Flanders (northern part of Belgium), score for DB and coccidiosis. On day 28, the same we used a systems thinking approach. To that end, data and samples were collected as in the study qualitative interviews were held with 33 relevant described above. stakeholders such as veterinarians (18), pig farmers Results: Preliminary results show no significant (10), and others (5). The themes emerging from correlation between footpad lesions, hock burns the thematic analysis were analysed by using a or crop filling and the DB score. A significant structural, functional and transformational analysis association was found between gender and the DB by which the SHS merits and failures were identified. score. Also analysis showed that some parameters A remarkable merit is the synchronisation of sector’s have only little influence on the total DB score. agreements and policies to reduce AMU in the pig A strong and significant correlation was present sector. Nevertheless, several systemic failures were between the DB score on D10 and the score on D20. observed such as the tradition that veterinary advice Dysbacteriosis and coccidiosis show a significant is provided for ‘free’ by feed mill companies, and the correlation in the animal until about 3 weeks of age. shortage of farm production data. Both failures may hinder swine practitioners to provide integrative Conclusion: The macroscopic lesion scoring is the advice. The fact that the sale of medicines is only method to diagnose DB, this study shows that the largest constituent of veterinarians income this method is very subjective and an objective constitutes a conflict of interest when veterinarians method is needed. This study also points out advise treatments (e.g. vaccines, antimicrobials). that screening of broilers on an earlier age for As a result farmers distrust often veterinarians dysbacteriosis can be indicative for the further vaccination advice. On a positive note, veterinarians development of the disease, making it possible to and farmers suggested alternatives to the ensure a more adequate approach. traditional business model. However, the broader institutional and socio-cultural environment does not facilitate this evolution. Our findings provide information on barriers and incentives influencing the implementation of policies and can aid policy makers and risk managers to anticipate the effects of their proposed policies, so that they can be fine- tuned before being enforced.

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158. Antimicrobial resistance of E. coli the exposure of Swiss consumers in a systematic and Salmonella in broiler chicken along literature review of data published between 1996 and the food chain in Canada 2016. Data from 313 out of 9,473 collected studies were extracted yielding 122,438 food samples and 38,362 bacteria isolates of which 30,092 samples ROMERO BARRIOS Pablo and 8,799 isolates were AMR positive. A median Canadian Food Inspection Agency (CFIA) AMRB prevalence of >50% was observed for Daniel LeClair – CFIA, meat and seafood harbouring Campylobacter, Enterococcus, Salmonella, E. coli, Listeria and Vibrio Anne Deckert, Andrea Desruisseau, Jane Parmley, Richard spp. and to a lesser prevalence for milk products Reid-Smith – Public Health Agency of Canada (PHAC) harbouring starter culture bacteria. Gram-negative Antimicrobial resistance is a major global public AMRB featured AMR against aminoglycosides, health threat today. The main purpose of this study cephalosporins, fluoroquinolones, penicillins, was to determine antimicrobial resistance in generic sulfonamides and tetracyclines observed at AMR E. coli and Salmonella from broiler chickens and exposures scores of levels 1 (medium) and 2 (high) for broiler chicken meat along the food chain (from Campylobacter, Salmonella, E. coli in meat as well entry into the slaughterhouse through to sale at as Vibrio and E. coli in seafood. Gram-positive AMRB retail outlets) in various geographical areas across featured AMR against glycoproteins, lincosamides, Canada. Isolates from a national microbiological macrolides and nitrofurans for Staphylococcus and baseline study conducted in 2012–2013 were subject Enterococcus in meat sources, Staphylococcus in to antimicrobial susceptibility testing for a set of 15 seafood as well as Enterococcus and technologically antimicrobials, using the same methods as those important bacteria (incl. starters) in fermented performed by the Canadian Integrated Programme or processed dairy products. Knowledge gaps for Antimicrobial Resistance Surveillance. Analysis were identified for AMR prevalence in dairy, of the results showed that of the 1,135 generic E. plant, fermented meat and novel food products coli isolates tested, 940 (83%) were resistant to at and for the role of specific indicator bacteria least one antimicrobial, as were 879 (59%) of the (Staphylococcus, Enterococcus), starter culture 1,495 Salmonella isolates tested. Resistance was bacteria and their mobile genetic elements in AMR most common to aminoglycosides, β-lactams, gene transfer. Raw meat, milk, seafood and certain tetracyclines and, for generic E. coli isolates only, fermented dairy products featured a medium to to folate inhibitors. Differences in antimicrobial high potential of AMR exposure for Gram-negative resistance patterns were observed across the and Gram-positive foodborne pathogens and provinces or regions, but not between the different indicator bacteria. For retail food, additional food stages of the food chain, season or the type of categories including fermented and novel foods as product sampled. There were also considerable well as technologically important bacteria and AMR differences in resistance among Salmonella genetics are recommended to be better integrated serovars, with most S. enteritidis isolates being into systematic One Health AMR surveillance and susceptible. This work provides a good cross- mitigation strategies to close observed knowledge sectional representation of the patterns of gaps and enable a comprehensive AMR risk antimicrobial resistance in the poultry production assessment for consumers. chain in Canada and serves as a useful benchmark for ongoing and future surveillance efforts. 160. Identification of antimicrobial resistance genes occurring in the diary food chain 159. Systematic literature review through functional metagenomics of antimicrobial resistance in bacteria isolated from retail food as a prerequisite SIMON Ancuta Cezara for a consumer exposure assessment Department of Food Hygiene and Technology and Institute of Food Science and Technology, University of SARNO Eleonora León, Spain; University of Parma, Italy EFSA; University of Zurich, Switzerland Amal Awad – Mansoura University, Egypt Christoph Jans – ETH Zurich, Switzerland Elena A Oniciuc – Department of Food Hygiene and Technology and Institute of Food Science and Technology, Lucie Collineau – SAFOSO, Switzerland University of León, Spain/Dunarea de Jos, University of Leo Meile – ETH Zurich, Switzerland Galati, Romania Katharina Stärk – SAFOSO, Switzerland Paul D Cotter – Teagasc Food Research Centre, Mooreparf, Roger Stephan – University of Zurich, Switzerland Fermoy, Ireland Avelino Alvarez-Ordóñez – Department of Food Hygiene Antimicrobial resistance poses serious threats to and Technology and Institute of Food Science and public health. The spread of AMR bacteria (AMRB) Technology, University of León, Spain and the exchange of resistant genes between animals and humans via the food chain requires Functional metagenomics is a valuable culture- holistic approaches for risk mitigation. This study independent tool for studying the composition aimed to assess: (i) the AMRB prevalence in retail and evolution of different complex microbial food produced in Switzerland or imported; and (ii) ecosystems. Indeed, it has taken precedent over the traditional culture-dependent methods, by

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bringing new insights into genomes of difficult-to- the human food chain. Natural bacteriophages culture or non-culturable microorganisms. Such can provide a safe and effective alternative to complex bacterial communities can be found in antibiotics in controlling Salmonella in agriculture fermented foods, in which different microorganisms and food. Bacteriophages are viruses capable of (lactic acid bacteria) can be added to the final food only killing bacteria, and cannot infect animals matrix as a commercial starter or can be acquired or plants. As they are naturally abundant in the from the processing environment. Food-related environment, harmless to the human body, tasteless microbes can act as potential reservoirs of different and odourless, the Food and Drug Administration antimicrobial resistance genes (ARG), which, in (FDA) has granted bacteriophages the status addition, may be transferred horizontally to different ‘Generally Regarded as Safe’ (GRaS) for use in food foodborne pathogens. Having this in mind, this products. The aim of my research was to isolate a study aimed at identifying ARG occurring in the panel of bacteriophages that could be developed complex microbiota of fermented foods (milk and to treat and prevent Salmonella infection in pigs. dairy products) and their associated processing Twenty-two examples of bacteriophages were environment using a functional metagenomics isolated and all could lyse/kill 74 MDR strains that approach. A metagenomics library comprising had been isolated from outbreaks on pig farms by ≈22,000 recombinant clones was built containing the Animal and Plant Health Agency, UK. Genetic microbial DNA isolated from raw milk, dairy analysis revealed that the bacteriophages have products and environmental reservoirs within dairy desired virulence genotypes that validate their use processing industries. The recombinant library therapeutically. Furthermore two-bacteriophage was plated on Luria Bertani agar supplemented combinations could rapidly kill Salmonella in 2 h at with different concentrations of the antimicrobials a 10,000-fold increase in vitro and in the in vivo moth ampicillin, gentamicin, ciprofloxacin, tetracycline, larva infection models. The phages are heat-stable, cefotaxime, colistin, peracetic acid, benzalkonium which allows them to be dehydrated and stored as chloride and sodium hypochlorite. Thirty-two clones a powder, increasing their shelf life and versatility showing an increased resistance to one of the tested for use in the pig industry. Our important research antimicrobials were identified: one for ciprofloxacin could hugely improve animal and human health by (minimum inhibitory concentration (MIC) – 0.5 µg/ providing a very effective tool to tackle the ever- ml), one for gentamicin (MIC – 8 µg/ml), two for growing issue of antibiotic resistance. tetracycline (MIC – 16 µg/ml), three for cefotaxime (MIC – 0.008 µg/ml) and 25 for ampicillin (MIC – 16 µg/ml). Fosmid DNA from those resistant clones 162. Methicillin-resistant Staphylococcus was purified, subjected to restriction analysis using aureus in bulk milk of dairy farms ApaI endonuclease, and sequenced to identify the and exposed workers in the north-east of Italy ARG conveying resistance to those antimicrobials. This study evidences the usefulness of functional metagenomics for the identification of ARG, TOMAO Paola also from difficult-to-culture or non-culturable Istituto nazionale Assicurazione Infortuni sul Lavoro (National microorganisms, and shows that the dairy food Institute for Insurance against Accidents at Work) chain may serve as a reservoir for ARG. Lebana Bonfanti – Istituto Zooprofilattico delle Venezie, Legnaro (PD) Paolo Visca – Università Roma Tre, Rome 161. Developing natural bacteriophages, Annalisa Pantosti – Fernanda Pimentel de Araujo, Istituto friendly viruses, as an alternative Superiore di Sanità, Rome to antibiotics in the UK pig industry Antonio Battisti – Istituto Zooprofilattico del Lazio e della Toscana, Rome THANKI Anisha Fabrizio Agnoletti, Guido Di Martino, Laura Gagliazzo – Department of Infection, Immunity and Inflammation, Istituto Zooprofilattico delle Venezie, Legnaro (PD) University of Leicester, Leicester, LE1 7RH, UK Daniela Visaggio – Università Roma Tre, Rome Monica Monaco, Fernanda Pimentel de Araujo, Istituto Kit Healy, Nathan Brown, Andrew Millard – Department Superiore di Sanità, Rome of Infection, Immunity and Inflammation, University of Alessia Franco – Istituto Zooprofilattico del Lazio e della Leicester, Leicester, LE1 7RH, UK Toscana, Rome Dominic Chairman, Charlotte Evans – AHDB Pork, Fabrizio Cestaro, Gaddo Vincenzoni – Ulss20 Verona Stoneleigh Park, Warwickshire, CV8 2TL, UK Manlio Palei – Regione Friuli Venezia Giulia Martha Clokie – Department of Infection, Immunity and Inflammation, University of Leicester, Leicester, LE1 7RH, UK Paola Melis, Di Simona Renzi, Nicoletta Vonesch, Paola Tomao – INAIL, Rome, Italy The World Health Organisation has reported that 1 in 10 people world-wide suffer from food poisoning Background: Staphylococcus aureus is a causative each year. In total, 11.7% of infections are caused agent of bovine mastitis in dairy herds. Due to by contaminated pigmeat, as over a third of pigs its zoonotic potential, control of S. aureus is a are infected with Salmonella when slaughtered. significant economic and public health concern. However, treating infections by antibiotics in pigs The emergence of methicillin-resistant S. aureus is becoming less effective due to the surge in (MRSA) and the capacity of livestock-associated (LA) infections caused by multidrug-resistant (MDR) MRSA strains to infect humans pose the farming Salmonella strains on farms that have also entered community a risk for the acquisition of LA-MRSA. We

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characterised MRSA isolates from bulk milk in dairy The possibilities of NGS for risk assessment are ample, farms in the north-east of Italy. Nasal swabs from but so are the questions on the subject that need workers of the MRSA-positive farms were obtained to be addressed. In this work, we present a state-of- and all isolates were characterised by phenotypic the-art review on the application of NGS in relation and genotypic techniques. to microbial food risk assessment. One of the major strengths of NGS lies in its capacity to generate Methods: 618 dairy farms were enrolled, and each a lot of data, but to what extend can this wealth farm was sampled three times over 3 months. In be of use as part of hazard identification, hazard MRSA-positive farms, nasal swabs were collected characterisation and exposure assessment to perform from workers to assess S. aureus and MRSA carriage. a sound risk characterisation which in turn will allow Molecular characterisation of MRSA isolates included SCCmec, spa and multilocus sequence typing and to make evidence-based risk management decisions. antimicrobial susceptibility testing. Results: 24 farms (3.9%) were found to be positive 165. Mastitis pathogens isolated from for MRSA in dairy herds. Different STs types were samples of milk in dairy cows and sheep found: ST398, ST1, ST22, ST3, ST1476. Sixty-two per and their resistance against antimicrobial cent of these were characteristic of LA-MRSA. Eleven workers (out of 70 screened) belonging to nine agents different farms were positive for MRSA. In 8/9 farms a ZIGO František correspondence between MRSA isolates from nasal University of Veterinary Medicine and Pharmacy, swab and bulk tank milk was found. Department of Animal husbandry, Košice, Komenského 73, Conclusions: MRSA strains in farm workers and bulk 040 01, Slovakia milk showed strong genetic and epidemiological Martina Zigová – Vasiľ Milan correlation. Some strains showed the typical genotype of LA-MRSA, while others belonged to genotypes The aim of this study was to evaluate the prevalence more commonly associated with humans. These and effectiveness of different antibiotics against findings suggest transmission of the same strains mastitis-causing microorganisms in two herds of from animals to humans or vice versa. Moreover, the dairy cows and in two herds of dairy sheep. The study showed human MRSA carriage to be related diagnosis of mastitis was performed on the basis to animal exposure, frequency of animal contact of clinical examination of the udder, macroscopic and number of MRSA-positive animals in the farm. evaluation of milk, determination of somatic cell Farming practices should be implemented to count (SCC) and bacteriological examination of raw avoid the transmission and spread of MRSA among milk samples. All isolated pathogens were tested by animals and between animals and farm workers. in vitro test on Mueller-Hinton agar by disc methods 163. for resistance to 14 types of antibiotics. From a total of 1,120 samples about a quarter of the cow’s milk samples (22.3%) were positive in the California mastitis 164. Next generation sequencing in microbial test (CMT). Of these 15.2% contained pathogenic food risk assessment: are we there yet? microorganisms that caused intramammary infection (IMI); subclinical mastitis (11.3%) with SCC VAN HOORDE Koenraad under 400,000 was mainly due to coagulase- Ghent University negative staphylococci (CNS), Streptococcus uberis and coliform bacteria E. coli and Enterobacter Francis Butler – University College Dublin, Centre for Food aerogenes. From a total of 820 sheep milk samples, Safety 11.5% were positive for pathogenic microorganisms Despite the continued increase in rigorous control that caused IMI, mainly due to Staphylococcus and monitoring measures to assure safe food along aureus, Streptococcus agalactiae and CNS. From all the entire farm-to-fork chain, the past decade has tested bacteria that cause mastitis in cows and sheep, also witnessed an increase in microbial food alerts. higher sensitivity against tetradelta was observed Hence, research on food safety and quality remain (100% of Streptococcus agalactiae and Streptococcus of utmost importance. Complementary, at least as uberis, CNS), (94.4% of Staphylococcus aureus) with important, is the necessity to be able to assess the the highest number of bacterial isolates, followed potential microbial risks along the food chain. by cefalexin + kanamycin amoxicillin plus clavulanat acid and ceftiotur (100% of Streptococcus agalactiae Risk assessment relies on sound scientific data. and Streptococcus uberis). Resistance was observed Unfortunately, often, quality data are limited if against penicillin (22.2% of Staphylococcus aureus), not lacking. High-throughput tools such as next amoxicillin (22.2% of Staphylococcus aureus and 10.5% generation sequencing (NGS) potentially could fill of Streptococcus uberis) and streptomycin (22.2% of this gap. NGS applications are not new in the field Staphylococcus aureus and 52.7% of Streptococcus of food microbiology with applications ranging uberis). The use of antibiotics in the treatment of from pathogen detection along the food chain, food mastitis and other diseases in dairy ruminants can epidemiology studies, whole-genome analysis of have a negative impact on public health through the food-associated microorganisms up to describing increase in resistant bacteria or bacteria that produce complete food microbiomes. Yet, its application in resistance genes that pass into people directly or the area of microbial risk assessment is still largely indirectly. unexplored and faces important challenges.

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Nutrition species are consumed by various cultures world- wide. In the EU, all insects and their products are considered as novel foods (NF) according to the provisions of Regulation (EU) 2015/2283. The safety of 166. Association between nutrition such products must be evaluated before EU market and fertility in women of reproductive authorisation may be granted. age in the Netherlands EFSA’s Panel on Dietetic Products, Nutrition and Allergies assesses the safety of NF. The scientific ABREU Taymara and technical guidance for the preparation of Radboud University applications for authorisation of NF issued by EFSA assists applicants to prepare a comprehensive and Abreu, Taymara, Radboud University; van Rooij, Iris, Radboud University; van Gelder, Marleen, Radboud complete report to demonstrate the safety of the University; Roeleveld, Nel, Radboud University. under-evaluation NF. Compositional characterisation including, chemical and microbiological quality The prevalence of subfertility in the world’s and stability, production process, proposed population is approximately 10%. Some risk factors uses, anticipated intakes, nutritional value and related to subfertility have been identified, but toxicological parameters should be addressed. it is still essential to investigate modifiable risk In particular, regarding insects, the species, the factors involved in the deterioration of reproductive substrate used (i.e. Feed for the insects), and the health, such as nutrition. The present study aims methods for farming and processing and existing to explore to what extent subfertility is associated information on allergenicity may be important with preconceptional nutrition in women. This aspects to demonstrate safety. is a large exploratory study involving women A food derived from insects may be submitted as a of reproductive age enrolled in the PRegnancy NF pursuant to Article 11 of the Regulation but may and Infant DEvelopment (PRIDE) Study. Energy- also qualify as so-called traditional foods (TF) from adjusted macro- and micronutrient data from non-member countries, provided there is a history of diet only (dietary intake) and from diet and dietary food use outside the EU. EFSA will not perform a full supplements (total intake) were modelled in 3 safety assessment on such foods but focus on hazard different ways: in quartiles; per increment of daily identification and evaluate whether identified consumption; and compared to dietary reference hazards may pose risks to the EU consumers. values. Time-to-pregnancy (TTP) was the biological measure of subfertility. Cox proportional hazard regression models were used to estimate hazard ratios, with right censoring time of 12 months. The 168. The role of traditional nutrition analyses were adjusted for age, gravidity, smoking of indigenous people in the Arctic zone status, and caffeine consumption. 1,283 women were of Western Siberia in managing the risks eligible for the current study. Higher intake of folate of hypertension (dietary and total intake), vitamin A (total intake), vitamin B1 (dietary intake), vitamin B6 (dietary and total intake), vitamin D (dietary and total intake), ANDRONOV Sergei vitamin E (dietary and total intake), and linoleic acid State Institution Yamalo-Nenets autonomous okrug (dietary intake) were associated with prolonged [Scientific Centre of Arctic research] TTP. Weaker associations were suggested between Andrei Lobanov, Sergei Andronov, Rusian Kochkin, Liliya longer TTP and higher intake of alpha-linolenic acid Lobanova, Andrei Popov, Irina Protasova – State Institution (dietary intake), iron (dietary and total intake), and zinc Scientific Research Centre of the Arctic, Nadym, Russia (total intake). In summary, higher intake of several Elena Bogdanova – Arctic Federal University named after micronutrients seemed to be associated with subfertility M. Lomonosov, Arkhangelsk, Russia in women of reproductive age in the Netherlands. Irina Kobelkova – Federal Research Centre of Nutrition, Biotechnology and Food Safety, Moscow, Russia

Nenets people belong to the Samoyedic language 167. Safety assessment of insects group and inhabit the vast area that stretches along and their products as food by the the coast of the Arctic Ocean from the Kola European Food Safety Authority (EFSA) Peninsula in the west to the Taymyr Peninsula in the east. Their traditional occupation is nomadic herding AMUNDSEN Mathias and river fishing. It is crucial to provide the native European Food Safety Authority population of the Far North with venison and local Ermolaos Ververis, Emanuela Turla, Wolfgang Gelbmann – fish to maintain their health. The cross-sectional Nutrition Unit, EFSA study of diets of the indigenous population (Nenets) (n = 590, aged 42.2 ± 13.3 years) was carried out With globalisation, an increasing number of during expeditions to villages which are located in foodstuffs is trying to have a share in the European the north of Western Siberia (Yamal). All the patients Union (EU) market. Increasing demand for nutrient were examined by physician, cardiologist and sources has raised western world‘s interest towards pulmonologist. The actual diet during the previous edible insects. To date, approximately 2000 insect month was studied by means of frequency method.

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Non-linear logit regression with step-by-step of the products that they are marketing, and for inclusion of variables using the maximum likelihood EFSA itself: it is currently used by the EFSA NUTRI method was used to construct risk models. Unit and EFSA Panel on Dietetic Products, Nutrition Quantitative assessment of the risk of hypertension and Allergies (NDA Panel) for the assessment of was calculated as the odds ratio (OR). To the greatest novel foods as defined by Regulation (EU) 2015/2283. extent, the risk of developing hypertension reduced the consumption of pike (Esox lucius) OR – 11,4. Fish consumption of the Sig family influenced the 170. Lactobacillus and Bifidobacterium decline in hypertension is somewhat smaller: shokur (Coregonus nasus) OR – 2.0; vendace (Coregonus strains and compositions with nanoceria albula) OR – 1.9; muksun (Coregonus muksun) OR – reduce cholesterol levels in an obesity 1.4. The most favourable combination of products is mouse model reindeer meat + berries (OR – 1.39) and shokur + pike (OR – 1.67). The greatest flexibility preventive action BUBNOV Rostyslav combined with efficiency has venison, pike and Zabolotny Institute of Microbiology and Virology, NAS of Ukraine shokur that allows them to recommend as priority components of preventive nutrition. Rostyslav Bubnov, Lidiia Babenko, Liudmyla Lazarenko, Victoria Mokrozub, Oleksandr Demchenko, Oleksiy Nechepurenko, Mykola Spivak – Zabolotny Institute of Microbiology and Virology, National Academy of Sciences 169. The EFSA Compendium of Botanicals of Ukraine reported to contain naturally occurring Background: Lactobacillus and Bifidobacterium substances of possible concern for human strains demonstrated efficacy to reduce cholesterol health and its use for the assessment on obesity model in our recent study. New updated of plant-based novel foods prebiotic concept on supposes perspectives to search for new substances. The aim of this study was BARTAKOVA Pavla to evaluate ability of Lactobacillus and Bifidobacteria European Food Safety Authority strains and compositions with nanoceria to reduce cholesterol level on obesity model in mice. Bernard Bottex – Scientific Committee & Emerging Risks Unit, EFSA Materials and Methods: We used female mice of Krystof Dibusz – EcoMole Ltd two lines: BALB/c 6–8 weeks mice (18–24 g), and mice of the CVA line, aged 11–12 months (20–26 g), Emanuela Turla – EFSA Nutrition Unit experimental animals were fed by fat-enriched diet. Botanicals and derived preparations made from Animals were divided into 15 groups to test probiotic plants have become widely available on the EU strains and nanoceria. All groups except the control market. Such products are typically labelled as received a special diet during three weeks before the natural foods and various claims are made regarding experiment. All groups received probiotic strains and their possible health benefits. They can be bought orally and intravenously cerium dioxide in various over the counter in pharmacies, supermarkets, composition. One groups of intact animals was specialist shops and via the internet. While most of control. Cholesterol level, liver morphology and gut these products have a long history of use in Europe, microbiota of mice were studied. some concerns exist about their safety and quality. Results: We revealed that all of studied probiotic Member States Competent Authorities expressed bacteria and composition of B. animalis VKL/B. the need for a toolkit to help them assessing the animalis VKB /L. casei IMV B-7280 decreased the safety of the plant-based products on their market. weight of obese BALB/c mice; nanoceria and probiotic The EFSA Scientific Committee therefore developed strains of L. casei ІМВ В-7280, B. animalis VKB and a compendium of botanicals reported to contain B. animalis VKL reduced levels of free and bound naturally occurring substances of possible concern cholesterol in serum. The combination of 0.01 M for human health. Such compendium is not nanoceria and probiotic strain L. casei ІМВ В-7280 at intended to conclude on the safety or non-safety initial administration resulted in the fastest decrease in of the listed botanical species but to help with cholesterol levels in young and adult animals. the safety assessment of botanicals and botanical preparations intended for use in food, including Conclusion: Nanocerium and probiotic strains of L. supplements, by facilitating hazard identification. casei IMV B-7280, B. animalis VKB and B. animalis Starting from plant lists existing at national level VKL reduce the levels of free and bound cholesterol both within and outside of Europe, EFSA outsourced in serum. This finding provides novel nutritional the literature search for around 2,600 plant species, insight for using probiotics compositions and for and the extraction of information regarding the considering nanomaterials as safe and effective plant composition, toxicity and case reports of prebiotic substances. adverse effects. Once the collected information has been validated by the EFSA Scientific Committee Working Group on botanicals, it is then made freely available on the EFSA website. The Compendium is intended for Member States Competent Authorities, for manufacturers who are responsible for the safety

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171. ChoEasy: a new tool developed 172. Protein profile and allergenicity to encourage healthier food choices of edible silkworm (Bombyx mori) pupae as affected by gender, rearing substrate CACCAVELLI Giovanna and processing SPRIM Italia

Giovanna Caccavelli, Alessandra Ciliberto, Laura Primavesi, CIRRINCIONE Simona Emmanuel Pauze– Center Study SPRIM, Nutrition National Research Council Italy Department, Via Brisa 3, 20133 Milan, Italy Simona Cirrincione, Francesco Gai – Institute of Science of Background: Poor nutrition plays a major role in Food Production National Research Council Italy the epidemic of various diseases, including obesity, Silvia Cappellozza, Alessio Saviane – CREA – Honey Bee type 2 diabetes (T2D) and cardiovascular disease and Silkworm Research Unit Italy (CVD). Recently, nutrition research and public health Marcello Manfredi, Emilio Marengo – University of Easter institutions are focusing on the effectiveness of Piedmont Italy various types of intervention encouraging healthier Maria Gabriella Giuffrida, Laura Cavallarin, Cristina food choices. Based on the current state of the art, Lamberti – Institute of Science of Food Production, National Research Council Italy we developed a new tool supporting healthier food choices practically at a population level. Edible insects, a traditionally food in Asia, can Methods: We went through four phases to develop be a source of sustainable protein with low our innovative tool: (i) design of scientific evaluation environmental impact [1]. Among these, the model, based on scientific literature and on reference silkworm (Bombyx mori) pupae (SWP) has been intakes for nutrients (RI, EU Reg No. 1169/2011); (ii) included in the list of insect species with the tool implementation, by setting an international biggest potential to be used as food and feed in food repository to hold all the products data; (iii) the EU, even if a specific risk assessment should data capture, to collect all the products information be performed, including the evaluation of the through an ad hoc smartphone App based on the allergenic potential associated to entomophagy optical character recognition (OCR) technology; and [2]. In this work, the protein profile of SWP was (iv) data analysis and nutritional products scoring characterised by 2D-PAGE coupled to LC-MS/MS, according to their nutrients content. to detect differences in protein expression related to the gender and to the diet (artificial or mulberry Results: More than 100,000 packed foods (85% from leaves). The SWP proteome analysis highlighted European countries) were scanned and classed differences in abundance of several proteins, some into categories according to consumers purchasing of them strictly related to a single condition (gender needs (e.g. raw cookies, skimmed yogurt). We or diet). Considering the sex-differentially regulated observed an important variability among scores of proteins, seven proteins better discriminated products in the same category. the sex effect (e.g. vitellogenin). As far as diet Conclusions: Considering the wide variability among was concerned, five proteins were found highly similar products, a tool like ChoEasy (e.g. used by related to the diet effect (e.g. bifunctional purine consumers through a dedicated App) could easily biosynthesis protein). Allergenicity of raw and fried support the identification of healthier options with SWP proteins was assessed by immunoblotting less salt, sugars and saturates. Considering a daily with sera of patients who were allergic to a different breakfast with cereals, whole yogurt and orange insect species (Tenebrio molitor). Processing (frying) juice, we calculated that with ChoEasy it is possible was shown to enhance the IgE binding of both to reduce up to 5 kg of sugars and 700 g of saturates SWP reared on artificial and mulberry leaves diet. in 1 year without changing people breakfast habits. Moreover, overall proteomic investigation of SPW Along with other educational programmes, ChoEasy revealed the presence of three known allergens: could easily and effectively improve the diet arginine kinase, chitinase and 27-kDa glycoprotein. composition in the population. Furthermore, it may In conclusion, the study supports the importance give a new momentum to products reformulation. of the comprehensive protein characterisation of novel foods, to assess the risk associated to their consumption. References [1] FAO (20130), Edible insects: future prospects for food and feed security. Rome. [2] EFSA Scientific Committee (2015), EFSA Journal, 13 (10):4257

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173. Iron intake in the Portuguese demands expanding outside Asian markets. university population Known for its nutritional and medical value in the Chinese pharmacopoeia, jellyfish seem to have characteristics of healthy food. Some Mediterranean CORBALAN Marina jellyfish species (phylum Cnidaria) can represent University of Murcia a low-cost raw material for innovative medical, Jose Antonio Latorre – University of Murcia nutraceutical or cosmeceutical products. Jellyfish Nuria Gimenez – University of Isabel I are rich in protein, mainly collagen and are recently designated as novel foods in Europe. Several Manuel Martinez-Bebia – University of Murcia compounds isolated from jellyfish, including Celia Monteagudo – University of Granada. proteins, can exert high antioxidant and other Antonia Maria Jimenez-Montrea – University of Murcia biological activities. GoJelly is a new H2020-funded Miguel Mariscal-Arcas – University of Granada project addressing the potential exploitation of jellyfish biomass and derived compounds for Introduction: University students have disturbed lifestyles multiple purposes. Here we report on the protein and eating habits. Although iron is found in very small characterisation of Rhizostoma pulmo, an edible quantities in our bodies, it participates as a cofactor in scyphozoan jellyfish regularly found with large numerous biological processes that are essential for life, populations along Italian sandy coastlines. We show such as oxygen transport, oxidative phosphorylation, that hydrolysed proteins, including hydrolysed neurotransmitter metabolism and deoxyribonucleic acid jellyfish collagen, have strong antioxidant activity, synthesis. Iron deficiency is the most prevalent nutritional particularly low-molecular-weight fractions (less deficiency world-wide and the leading cause of anaemia. than 10 kDa). Moreover, the cytotoxicity of different Objective: Evaluation of iron intake by sex in the Portuguese fractions of jellyfish hydrolysed protein on cancer university population through the 24 hours recall. cells (MCF7) and human keratinocytes (HEKa) was investigated, as well as their protective effect on Methods: The population is made up of 159 students UV-irradiated HEKa. In combination with food safety from the University of Porto. The population sample is assessments and improvements in jellyfish processing made up of 159 students from the University of Porto technology, scientific evidence demonstrating edible and is between 17 and 36 years old with a mean age of jellyfish as functional food may promote the future 21.57 years (Standard Deviation (SD) 3.00), distributed expansion of jellyfish fishery world-wide. among 54.1% of women and 45.9% of men. A 3-day 24 hours recall questionnaire were used. For the study of iron intake by gender, the T-test (P ≤ 0.05) was used, together with the minimum, maximum, mean and SD 175. Dietary supplement use in Europe values. For the evaluation of the diet the programme – an overview based on national dietary © Healthium 2017 was used. Nutrium.io used Microsoft surveys Excel 2010 and IBM SPSS Statistics Version 23 for the nutritional evaluation of the foods contained in the 24 DIERKES Jutta hours recall and for statistical evaluation. Dept of Clinical Medicine, Centre for Nutrition, University of Results and conclusion: The mean iron intake for Bergen, Norway men was 8.83 mg (SD 2.77) and 8.09 mg (SD 2.69) for Natasha L Welland – Dept of Clinical Medicine, Centre for women, the recommendations for the Portuguese Nutrition, University of Bergen, Norway population being 10 mg for men and 16 mg for women, with no statistically significant differences Background: The percentage of dietary supplement when comparing iron intake by gender. users has increased over the last decades in several European countries. Dietary supplements may be used to correct nutritional deficiencies or maintain 174. Jellyfish proteins as bioactive an adequate intake of certain nutrients. compounds in novel foods Objective: Data from national dietary surveys on available data on the percentage of dietary DE RINALDIS Gianluca supplement consumers and the level of intakes of National Research Council, Institute of Sciences of Food dietary supplements in adults (12 countries). Production (CNR-ISPA), Lecce, Italy; University of Siena, Results: The frequency of participants using Siena, Italy dietary supplements ranged from 5% (Italy) to 62% (Denmark). Frequency of supplement use M Paulmery – University of Lille, Lille, France was higher in women compared with men and A Gallo – CNR-ISPA, Lecce, Italy increased with age and duration of education G Bleve – CNR-ISPA, Lecce, Italy in most countries. Multivitamins/minerals and S Piraino – CNR-ISPA, Lecce, Italy; University of Salento, omega-3 fatty acids were the most frequent used Lecce, Italy supplements. Vitamin D was the single vitamin that A. Leone – CNR-ISPA, Lecce, Italy was most often used. Different assessment methods made the comparison between countries difficult. The edible jellyfish world fishery, mostly based in Southeast Asia, generates a global catch annually Conclusion: The frequency of dietary supplement exceeding 750,000 tonnes, with increasing use is relatively high in most of the European

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countries investigated, but further harmonised 177. A Geography of Nutrition: eating investigation is needed. There is a need for habits, mobility and school performance, more accurate and detailed dietary supplement a study in the city of Lisbon consumption data derived form a harmonised methodology across Europe. The national food consumption surveys also need to adapt FERREIRA Jorge methodology to include estimates from supplement Nova University of Lisbon sources in the surveys, and to develop improved methods for estimating intakes of micronutrients According to the World Health Organisation (WHO), from dietary supplements. overweight and childhood obesity are one of the major public health problems of the 21st century. This pathology has increased at a high rate, being 176. The effect of the regulation on the very common in urban areas. By 2013, overweight affected about 42 million children under the age trans-fatty acid content of foods in Hungary of five world-wide. By 2015 in Portugal, 25% of boys and 31% of girls between the ages of 11 and 15 were ERDEI Gergő overweight or obese, which were only surpassed by National Institute of Food and Pharmacy the United Kingdom and Greece. Anita Varga, Márta Bakacs, Eszter Sarkadi-Nagy On a daily basis, children spend much of their time in school where they eat most of their meals. Taking Artificial trans-fatty acids (TFA) are formed during these data into account, it will be important to the industrial processing of foods, and are proven to understand which factors influence young people’s be harmful for the human body. Their consumption nutrition, so that the incidence of overweight and has been associated with an increased risk of obesity can be prevented and reduced. cardiovascular disease, abdominal obesity, diabetes and certain types of cancer. Decree 71/2013. (XI. 20.) The mobility of the student will also be studied, of the Ministry of Human Capacities, which has especially the routes between the school and the been in force since 18 February 2014, defines the catering establishments where the students can highest permitted amount of TFA in food products move, in a normal day of school activity. placed on the market in Hungary. The official control This research will use spatial analysis, namely of TFA content of foods is performed by the food Geographic Information Systems (GIS). These will chain safety and animal health directorates of the allow overlapping layers of information from multiple capital and county government offices. The National sources, so integrating two fields of study that usually Food Chain Safety Office aggregates and forwards do not intersect: Geography and Nutrition. the data to the National Institute of Pharmacy and Nutrition (OGYÉI). Data of the TFA content of food The aim is to relate dietary habits, physical activity, products for the pre-regulation period were derived mobility and nutritional status with the food supply from the database of the National Institute for Food in the school geographic zone and the students’ and Nutrition Science. school performance. So, this study will allow: Between 2010 and 2016 the total number of the georeferencing the availability of catering measured products was 1,586 with special emphasis establishments and the like in a certain area of on biscuits, cakes, wafers, bakery products/fine influence with school equipment; bakery products, chocolates, products made from correlating the nutritional variables with the chocolate compound, vegetable fats. 900 products performance of the school population (12 and 17 years); were measured before the Regulation (2010–2013) and 686 products were measured after (2014–2016). analysing variations in eating habits in two areas of Before the regulation an average of 20% of the the city of Lisbon. food products had trans-fatty acid content above the threshold and after the regulation entered into force a significant improvement was observed. In 178. Impact of drought on the nutrient 2016, only less than 2% of the products exceeded the content of food crops: A neglected permitted limits. climate change issue? The regulation has reached its goal, due to the legislation the number of food products with high FISCHER Sahrah trans-fatty acid content has been drastically declined. Institute of Agricultural Sciences in the Tropics (Hans- Ruthenberg-Institute) (490), University of Hohenheim

Thomas Hilger, Georg Cadisch – Institute of Agricultural Sciences in the Tropics (Hans-Ruthenberg-Institute) (490), University of Hohenheim

Plants are the main source of human nutrients, and in turn gather their nutrients from the soil. Together soil and environmental factors like weather control bioavailability of nutrients to plants, and so

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to food. With increasing extreme weather events, a day every day, 10% eat fruit less than once a week, drought periods affect plant growth but also affect while 2% of students never consume fruit. Vegetable bioavailability of nutrients and hence severely affect consumption showed similar frequency. Fruit and food quality. This study compares two regions in vegetables were more likely to be consumed by East Africa (Kapchorwa, Uganda; Busia, Kenya) that younger and students with better socioeconomic experienced drought during the second growing status. Every fourth student consumed sweets more season in 2016. The main research questions were: than once a day (23.6%) and every tenth student (i) does drought have an impact on the nutrient consumed cola or similar non-alcoholic beverages composition of produced food; and (ii) does drought every day. Underweight as well as overweight and affect crops differently when grown on soils of obesity prevalence decreases with age: the highest varying fertility? prevalence of underweight students was among girls aged 11 (6.2%), while in the same age group boys For this study, we collected 127 maize (Zea mays) were more often overweight (25.6%) and obese (19.3%). grain samples per region and season from 142 randomly selected households during the long Conclusion: There is increasing need for further rain season (March to August) (LRS) and the short preventive interventions targeting younger rain season (October to December) (SRS) of 2016. adolescents aiming at improving diet habits and Crop and soil samples were analysed using a pX nutritional status. rheumatoid factor (RF) (Bruker©) for magnesium, phosphorus, sulfur, potassium, calcium, manganese, iron, zinc and copper. Soil properties nitrogen, 180. From a mechanistic risk assessment carbon, C:N, texture, pH and eCEC were measured. to a global risk management, from total Kapchorwa has higher soil fertility than Busia, and to free sugars during the LRS all monitored grain nutrients were significantly higher in Kapchorwa. Yield decreased HOUDART Sabine significantly between LRS and SRS due to drought, ANSES (French Agency for Food, Environmental and in both regions. In Kapchorwa, maize showed a Occupational Health & Safety ) significant decrease of 42% in nutrient content from the LRS to the SRS. In Busia, however, maize showed Luc Tappy – University of Lausanne a significant increase of 41% in nutrient content from Irini Margaritis – ANSES the LRS to the SRS. The contradicting results are due to a complete cessation of rainfall in Kapchorwa Background and objectives: This work aims to before grain filling, whereas in Busia rainfall ceased assess the scientific evidence linking sugar intake directly after. These unexpected results indicate that and health in the adult population to establish extreme weather events have unpredictable effects recommendations for consumers and risk managers on quantity and quality of food. There is need for taking into account the social and political context of more research into bioavailability of crop nutrients. sugar consumption Material and methods: A literature search on the effects of sugar intake on overweight/obesity, 179. Diet habits and nutritional status diabetes/insulin resistance, dyslipidaemia/ in school aged children in Serbia – data cardiovascular diseases, non-alcoholic fatty liver from Health Behaviour in School-age diseases and uric acid concentrations focused on Children Survey study 2017 controlled mechanistic studies, prospective cohort studies and randomised clinical trials. GUDELJ RAKIC Jelena Result: Literature analysis supported a direct link Institute of Public Health of Serbia ‘Dr Milan Jovanovic Batut’ between fructose intake and blood lipids and an indirect link, mediated by an increase in total energy Aim: The aim was to examine diet habits and intake, between sugar intake (mainly documented nutritional status and their association with for sugar-sweetened beverages, SSBs) and body demographic, socioeconomic and lifestyle factors weight. In addition, prospective cohort studies among Serbian schoolaged children. showed associations between sugar intake and risk of diabetes/insulin resistance, cardiovascular Method: Data were obtained from the Pilot diseases, NAFLD and hyperuricemia. These results Health Behaviour in School-age Children Survey allow setting a maximum limit to the intake of (HBSC) performed in spring 2017. Self-completion total sugars containing fructose (sucrose, glucose– questionnaire was administered in 86 schools and fructose syrups, honey or other syrups and natural completed by 3,267 students aged 10 to 17 years concentrates, etc.) at 100 g/day. Moreover, as there (1,682 boys i.e. 51%, 1,585 girls i.e. 49%). was no evidence that sugars naturally present in Results: Results showed that during the working fruits and vegetables and ‘free sugars’ (including week, more than half of the students (54.3%) added sugars and fruit juices) would be differentially consume breakfast every day, while 6.7% never metabolised in the body, this maximum limit eat breakfast. Among those who never consume comprises all sources of sugars, excluding lactose breakfast on weekdays or weekends are and galactose. predominantly students with low socioeconomic status. Every fifth student (19.3%) consume fruit once

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Conclusions: This recommendation of a maximal 1,291.7 (1,017.2–1,591.4) mg/day for phosphorus and daily intake of 100 g for total sugar does by no 323.2 (260.3–396.6) mg/day for magnesium. The means challenge the beneficial effects of fruit and calcium–phosphorus (Ca/P) ratio in this study was vegetable consumption that has to be promoted. 0.63 (0.52–0.73). These values are in agreement with Indeed, the optimisation tool deployed by ANSES those suggested by European and international to update food consumption guidelines for the recommended intake for adult population, with French population shows that when this limit is the exception of calcium which is slightly lower observed simultaneously with other constrains (41 than recommended values and suggests that this dietary reference values and toxicological reference population does not present nutritional deficiencies values for around a hundred contaminants), fruits requiring any supplementation. provide around 40 g of sugars and vegetables 6 g of sugars. This result is consistent with the WHO recommendation to limit free sugar intake to less 182. Risk assessment of Gymnema than 10% of the total energy intake. As it is estimated that 20 to 30% of French adults (in the INCA 2 survey) sylvestre preparations in food currently have daily sugar intakes (excluding lactose supplements and galactose) above 100 g/day, effective public health actions will be needed to reduce free sugar MARAKIS Georgios* consumption, especially SSBs. These actions should Hellenic Food Authority target a wide range of spheres, from consumer education and information to regulatory measures Rainer Ziegenhagen, Alfonso Lampen, Karen I Hirsch-Ernst – German Federal Institute for Risk Assessment (BfR) aimed at decreasing the levels of free sugars in strategic food products. The plant Gymnema sylvestre and its botanical preparations have a long tradition of use for medicinal purposes. Gymnema preparations are 181. Dietary intake of calcium, phosphorus currently being marketed as an ingredient of certain and magnesium in a northern Italian food supplements, either alone or in combination community with other herbs and/or micronutrients, and are typically being used by people displaying one or more symptoms of metabolic syndrome. Food MALAVOLTI Marcella supplement use may occur without medical University of Modena and Reggio Emilia (UNIMORE) supervision; it is therefore not unlikely that Tommaso Filippini, Carlotta Malagoli, Silvia Cilloni, Gymnema-based food supplements may also Federica Violi – UNIMORE be consumed instead of or in combination with Luciano Vescovi – IREN (RE) allopathic drugs. Marco Vinceti – UNIMORE In the present project, an assessment of potential health risks associated with the use of Gymnema Minerals are essential micronutrients for growth, botanical preparations was performed. Electronic development and maintenance of healthy tissues, searches of the literature were conducted in the long-term insufficient intake of minerals may PubMed Medline and EMBASE databases. lead to bone demineralisation and often requires the use of food supplements. The ratios of certain The limited information currently provided by animal minerals intake like calcium and phosphorus are toxicological studies has so far not suggested serious also proved to affect the bioavailability of calcium adverse effects on organ functions. Clinical trials and even lead to adverse health consequence. This mainly involving type I and type II diabetic patients study was designed to explore the dietary sources have suggested the potential for specific Gymnema of calcium (Ca), phosphorus (P), and magnesium preparations to lower blood sugar levels, but also (Mg) and the ratios between different minerals to promote hypoglycaemia when administered (Ca/P). We measured the content of these elements together with insulin or antidiabetic drugs. A in foods that compose a typical Italian diet using number of in vitro studies have demonstrated that inductively coupled plasma-mass spectrometry and certain Gymnema extracts modulated the activity we estimated their daily dietary intakes assessed of particular xenobiotic-metabolising cytochrome through a semi-quantitative food frequency P450 enzymes and of certain xenobiotic (ABC) questionnaire specifically developed within the transporters, indicating possible pharmacokinetically European Prospective Investigation into Cancer based interactions of Gymnema with certain drugs. and Nutrition (EPIC) study in a northern Italian Moreover, in vivo studies suggested that certain community. In 890 analysed food samples the extracts may potentiate the glucose and lipid main contributors to calcium are milk and dietary lowering effects of specific drugs. Finally, a case products, dry fruits, legumes and sweet products. report of liver toxicity related to the consumption Important sources of phosphorus are represented of Gymnema tea has raised concern regarding by dry fruits, legumes, milk and dairy products the possibility of adulteration or contamination of and meat. While dry fruits, legumes, cereals and the tea with hepatotoxic substances. Considering fish symbolised the most important sources for the uncertainties regarding the composition magnesium. In our Italian population sample, the of different Gymnema preparations, potential estimated median (interquartile range) dietary daily herb–drug interactions and concerns about intakes are 786.3 (592.2–1062.7) μg/day for calcium; hypoglycaemic effects, the use of Gymnema-based

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food supplements without medical supervision as 184. Pre-clinical safety assessment a substitute for (or in combination with) authorised of human-identical milk oligosaccharides antidiabetic drugs may be associated with risks. in neonatal rats Georgios Marakisis an EFSA EU-FORA fellow at BfR.

MIKŠ Marta Glycom A/S, Kogle Allé 4, Hørsholm, DK-2970, Denmark; 183. Intake of iodine in Mediterranean University of Warmia and Mazury in Olsztyn, Faculty of population with elevated thyroid disease Food Science, Plac Cieszynski 1, 10-726, Olsztyn, Poland index Christoph H Röhrig – Glycom A/S, Kogle Allé 4, Hørsholm, DK-2970, Denmark MARISCAL-ARCAS Miguel Kirt R. Phipps, Nigel Baldwin – Intertek Scientific & University of Granada Regulatory Consultancy, Room 1036, Building A8, Cody Technology Park, Ively Road, Farnborough, Hampshire, Nuria Gimenez-Blasi – University of Isabel I GU14 0LX, UK Jose Antonio Latorre, Manuel Martinez-Bebia – University Barry Lynch – Intertek Scientific & Regulatory Consultancy, of Murcia 2233 Argentia Road, Suite 308, Mississauga, Ontario, L5N Ana Pascual, Tara Rendo, Maria Soto – University of Isabel I 2X7, Canada Magdalena Martinez-Tome – University of Murcia After lactose and lipids, human milk Rosario Pastor – University of Avila oligosaccharides (HMOs) are recognised as the third Miguel Mariscal-Arcas – University of Granada largest solid component of human breast milk, with Introduction: The murcian population (southeast of a wide diversity of over 200 identified structures and Spain) exhibit a high risk of thyroid diseases. concentrations significantly higher than in most other mammalian milks. HMOs offer numerous Objective: To know the iodine intake of the murcian potential health benefits to infants, children and adult population and the foods through which this adults, so they are recognised as a novel, important population access this nutrient. and attractive food ingredient category, particularly Method: The population studied was composed in infant nutrition. To simulate the composition of 150 individuals (18–80 years), (33.8% women and of human breast milk more closely, commercial 65.6% men). The nutrient and food intake was infant formula can be supplemented with human- evaluated by means of a 24-hour recall (R24h) identical milk oligosaccharides (HiMOs), which are and a questionnaire on the frequency of food manufactured to be structurally identical versions consumption (FFQ). Iodine intake was assessed of their naturally occurring counterparts. However, through the foods consumed by the population and before their commercialisation as infant formula that contribute this nutrient with linear regression. ingredients, the newly developed HiMOs should be subjected to pre-clinical safety assessment followed Results: There were no statistically significant by clinical trial. In this study, as part of the safety differences between men and women in iodine intake evaluation, two in vitro genotoxicity tests and a in the population under study, so it was determined subchronic oral gavage toxicity study (in neonatal to treat the population as a whole. This population Sprague-Dawley rats) were conducted. In the has an iodine intake of 88.43 μg/day, data obtained subchronic study, HiMOs were administered orally through the FFQ, showed that its main source of (by gavage) at three dose levels, once daily for at iodine came from fish (R2 = 0.78), followed by molluscs, least 90 days, followed by a 4-week treatment-free shellfish, spinach, canned fish, garlic, egg and carrot. period. An identically comprised reference control Approximately 1/3 (30.66%) of the individuals suffered group received fructooligosaccharides powder from diseases related to the thyroid gland or were at (a non-digestible oligosaccharide used in infant risk of suffering from disease. formula) to allow for direct comparison against the Conclusions: Knowing that the recommended high-dose group. Measurements included food iodine intake is 150 μg for a healthy adult population consumption, body weight, clinical observations, according to the recommendations for the blood biochemistry and haematology, urinalysis, adult Spanish population, this population had a ophthalmic and histopathological examination. The significant iodine deficit of almost 1/3 lower than the studied HiMOs were non-genotoxic in the in vitro recommendation. Its main source of this nutrient tests. There were no compound-related adverse is fish. Deficient iodine intake in the population effects in the 90-day study. These results support is related to thyroid problems, so an increase in the safe use of HiMOs in infant formula and as a the consumption of food from the area with good food ingredient, at levels not exceeding those found sources of iodine should be recommended and that naturally in human breast milk. is characteristic of a Mediterranean Diet.

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185. A new approach to define food- 186. Effect of thermal processing on based dietary guidelines the proteins profile and allergenicity of edible insects MORISE Anne ANSES NEBBIA Stefano Institute of Sciences of Food Production (ISPA), CNR, Italy Sandrine Wetzler, Sabrina Havard, Véronique Sirot, Irène Margaritis – ANSES Cristina Lamberti – ISPA, CNR, Italy The development of food-based dietary guidelines Veronica Giorgis – Department of Medical Sciences Allergy and Clinical Immunology, University of Torino & AO (FBDG) usually involves translating nutritional Mauriziano ‘Umberto I’Italy references into food combinations. In 2001, the FBDG Simona Basile – ISPA, CNR, Italy were based on the dietary patterns observed in the French adult population that provided the best Maria Gabriella Giuffrida – ISPA, CNR, Italy coverage of nutrient requirements. To define the new Giovanni Rolla – Department of Medical Sciences Allergy FBDG, an innovative approach was followed. This and Clinical Immunology University of Torino & AO Mauriziano ‘Umberto I’Italy, approach is not based on observed dietary patterns but on the public health goals considered here: Laura Cavallarin – ISPA, CNR, Italy to cover nutrient requirement for almost all the Edible insects are currently under study as an French population; alternative and sustainable protein source for humans, to meet the nutritional needs for the to prevent chronic non-communicable disease, growing world population. In Asia, where insects especially cardiovascular disease, cancers, diabetes, are routinely consumed as food, cases of allergic obesity; reactions have been reported. The evaluation of the to limit contaminant exposition and to prevent the allergenic potential associated to entomophagy is risk with regard to the contaminants. so a priority. Preliminary data on European patients indicate that the consumption of edible insects Moreover, to facilitate the acceptance and can trigger IgE-mediate reactions in subjects implementation of FBDG, French eating habits have allergic to proteins contained in animals belonging been taken into account. So, this global approach is to the same phylum, such as crustaceans and similar to a benefit–risk balance. To our knowledge, mites. Additional data generation, needed for it is the first time that FBDG integrate all these risk assessment on this topic, has been highly dimensions. recommended by EFSA. To define food patterns that reach these goals, a Four edible insects species were considered: buffalo mathematical algorithm has been developed. It worms (Alphitobius diaperinus), mealworms integrates: (Tenbrio molitor), cricket (Gryllodes sigillatus) scientific data such as the updated French nutrient and grasshopper (Locusta migratoria). Soluble references, data from analysis of articles on the and insoluble proteins were extracted from raw relationship between food group consumption and and processed (boiled and fried) insects and the the risk of chronic non-communicable diseases proteins profiles were analysed with SDS-PAGE and the health-based guidance values used in the electrophoresis. French Total Diet Study; In the two worms, similar proteins profile separation and ANSES databases for food consumption, were observed in raw and boiled insects, while in the nutrient composition and contaminant content of cricket and grasshopper boiling modified protein food, (respectively from INCA2, CIQUAL and TDS2). profiles. In all the insects, the protein profile of the fried samples strongly differed from the raw protein For the needs of the mathematical algorithm, a new profile. Aggregation phenomena were observed, food categorisation based on dietetic and usage as the processing temperature increased, with considerations was defined. a consequent increase in the insoluble proteins Optimised solutions proposed by the algorithm fraction extract. represent combinations of food groups that meet To evaluate the allergenicity of the four insects, IgE the set objectives by construction. cross-reactivity with crustaceans (n = 15) and house So the approach developed for the elaboration of dust mite (n = 30) in Italian patients was assessed, by FBDG is innovative, global and is conceived to be the immunoblotting and LC-MS/MS analysis on raw or more objective as possible. processed insect proteins. Processing differentially affected IgE immunoreactivity, depending on processing intensity and insect species. IgE cross- reactivity of insects proteins with crustaceans and house dust mite allergens is discussed.

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187. Diet adjustment in later life: 188. Antinutritional factors, in vitro a grounded theory study of eating trypsin, chymotrypsin and peptidase behaviours among the ageing population multienzyme protein digestibility of Limerick of some melon (egusi) seeds and their protein isolates O’FLAHERTY Sharon Limerick Institute of Technology (LIT) OGUNDELE Joan Industrial Chemistry Department, Federal University, Oye Ageing of the population going forwards will Ekiti, Ekiti State, Nigeria; Chemistry Department, Federal embody one of the most momentous demographic University of Technology, Akure, Ondo State, Nigeria and social developments encountered by Irish society. Falling fertility rates and ever-increasing In vitro multienzyme protein digestibility (IVMPD) life expectancy will see the number of older people and antinutritional factors (ANF): tannin, phytate and aged 60 or more almost double, with those over the oxalate of five melon (egusi) seed flours (MSF) and age of 75 expected to almost triple by the year 2050. their protein isolates (PI) were carried out. Their PI Older individuals are the fastest growing segment of have potential comparable with that of soya bean. It the world’s population, yet they are often overlooked is important to know the IVMPD and ANF of these by the food industry, with most food products protein sources to ensure their safety when adapted being targeted at those aged 21 to 49. Disruptions for use as alternate protein sources as a substitute in diet and eating behaviours are common among for cow’s milk, which is relatively expensive in older adults however, little information is known Nigeria. Standard methods were used to produce about the processes underlying these disruptions. PI from Citrullus colocynthis, Citrullus vulgaris, The central goal for assisting individuals to age African Wine Kettle gourd (Lageneria siceraria well is by promoting a healthy and nutritious I), Basket Ball gourd (Lagenaria siceraria II) and diet however, ‘Eating behaviour is the result of Bushel Giant Gourd (Lageneria siceraria III) seeds a complex interaction of physical, psycho-social, and to determine the ANF and IVMPD of the MSF cultural and environmental factors that impact and PI unheated and at 37°C. Multienzymes used food choices and dietary practices’ (Brownie & were trypsin, chymotrypsin and peptidase. IVMPD Coutts, 2014, p. 182). Conversely, the extent to which of MSF ranged from (70.67 ± 0.70)% (C. vulgaris) food shopping can constitute a manageable part to (72.07 ± 1.79)% (L. siceraria I) while for PI ranged of older adult’s daily/weekly routines is strongly from 74.33% (C. vulgaris) to 77.55% (L. siceraria III). influenced by their economic means and health IVMPD of the PI were higher than those of MSF. status. Addressing diet deficiencies will reduce diet- Heating increased the IVMPD of MSF with average related chronic metabolic diseases and diminish value of 79.40% and those of PI with average of malnourishment, by promoting positive health 84.14%. ANF averages in MSF are tannin (0.11 mg/g), outcomes for older cohorts. The aim of this study phytate (0.23%). Differences in IVMPD of MSF and was to identify potential barriers and motivators for their PI at different temperatures may arise from food intake in the ageing population. Qualitative processing conditions that alter the release of amino methods based on a Constructivist Grounded theory acids from proteins by enzymatic processes. ANF in approach, guided by a Critical Realist worldview MSF were relatively low, but were found to be lower were used. A mixture of 16 intensive interviews and in the PI, therefore making the PI safer for human 10 observations was carried out to accomplish the consumption as an alternate source of protein. research objectives. Data analysis was conducted using the software package NVivo. The sample criteria included those over the age of 65, living independent lives and who were responsible for 189. The addictive behaviour and brain – most of their own shopping and cooking needs. An leptin levels in long-term MSG-treated rats applicable theory of why and how older adult eating behaviours change in later life will be developed. ÖZYÜREK Özlem Results from this study indicate that dietary changes Erciyes University in later life are often the result of changing family structures and older people’s perceptions of what Asuman Gölgeli – Erciyes University, Faculty of Medicine, Department of Physiology, Kayseri, Turkey they believe they should eat. Participants from this study indicated their need for less food as a natural Monosodium glutamate (MSG) is used as a flavour process of ageing, However, research suggests older enhancer in many processed foods. In many adults should consume the same, if not higher levels countries there are no limitations on the amount of protein to offset malnourishment and prevent of MSG intake that is questioned due to its toxic anorexia of ageing. Findings from this study will effects on human health. Previous studies have provide a body of evidence that may help form shown that MSG administration during the early policies that are person centred and cost effective to post-natal period results in neurodegenerative health and social care sectors. changes in several forebrain regions, characterised by neuronal loss and neuroendocrine abnormalities. No consensus has been reached between food committees and researchers on the harmful effects of MSG. Experimental animal studies of MSG are

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carried out at high doses and on the developing a sustainable way for the production of food, drugs brain. The present study was designed to investigate and cosmetics. The AlgaeCeuticals project will take the in vivo effects of MSG on the addicted behaviour advantage of the native algae strains producing and brain leptin levels in rats. In this study, 8-week- high added value products and through the old male rats (n = 10) were given MSG (with gastric application of novel ’omics technologies (genomics, gavage) only one day in a week for 12 weeks. The transcriptomics, proteomics, enzymomics and control group rats (n = 10) were given saline at the metabolomics) as well as algae culture technologies same time and period. After the exposure period, and production of novel products. AlgaeCeuticals the animals were subjected to behavioural tests in will screen and characterise algae biodiversity, conditioned place preference (CPP) test and brain develop and optimise algae culture systems, leptin levels were analysed. There was no significant develop ’omics resources for algae and also develop difference between MSG and control groups in the downstream processing strategies and also develop time spent in the target segment (P > 0.05). There novel products. For this reason and to achieve its was no significant difference in the brain leptin levels object three academic and research centres from of MSG and control groups rats (P > 0.05). These Greece (CERTH/INAB; AUA) and Italy (FEM) will findings indicate that MSG has no addictive effect collaborate for 4 years with four industrial R&D at this dose in rats. However, MSG administration partners from Greece (Fresh Formula), Spain (Bionos at higher doses (two to three times a week) can be Biotech ND; Centro Tecnológico Nacional de la tried in another group of animals. Further research Conserva y Alimentación) and Austria (Ecoduna AG). is needed on the relationship between MSG and its Through this collaboration the academic partners addictive effect. will work closely with the industrial R&D and form a Funding complementary and highly competitive team that will promote transfer of knowledge and excellence to This study was supported by the Erciyes University Scientific Research Centre (BAP) (TYL-2016–6478). industrial partners. This will strengthen the industrial Key words: monosodium glutamate, addictive behaviour, competitiveness in the field of food and cosmetics leptine levels, condition place preference in the process of the design, development, testing of the products proposed by the project. Funding 190. AlgaeCeuticals: development Project Number: 778263. Funding scheme: H2020-MSCA- RISE-2017 (Marie Skłodowska-Curie Research and Innovation of microalgae-based natural UV Staff Exchange). sunscreens and proteins as cosmeceuticals and nutraceuticals 191. Use of mathematical optimisation PALMIERI Luisa to derive personalised dietary Fondazione Edmund Mach, Italy recommendations Panagiotis Madesis – Institute of Applied Biosciences, Centre for Research and Technology Hellas – CERTH, PERSSON Maria 6th km Harilaou-Thermi Road, PO Box 60361, GR570 01, Sisse Fagt, Sara Pires, Morten Poulsen, Maarten Nauta – Thermi, Thessaloniki, Greece National Food Institute, Technical University of Denmark Nikos Labrou – Laboratory of Enzyme Technology, Department of Biotechnology, Agricultural University of Athens, Iera Odos 75, Gr-11855, Athens, Greece Consumption patterns in a population often vary Leonardo Cerasino, Nico Salmaso, Stefan Martens – IASMA greatly and national dietary guidelines may be Research and Innovation Centre, Fondazione Edmund perceived as unrealistic by a substantial part of the Mach, via E. Mach, 1, 38010 San Michele all’Adige (TN), Italy population, as they differ considerably from individual Silvia Fluch – ecoduna AG | eparella GmbH, Szallasweg 2, preferences. Personalised recommendations may 2460 Bruck an der Leitha, Austria be more relevant and have stronger motivational Pablo Flores Ruiz, Ángel Martínez Sanmartin – Centro effects, because these can account for e.g. personal Tecnológico Nacional de la Conserva y Alimentación preferences, needs and beliefs. Hence, personalised CTNC, Spain recommendations may have a positive impact Jose Mullor – Bionos Biotech S.L., Biopolo La Fe – Hospital on public health, as higher compliance to the La Fe, torre A, 1ª planta Av. Fernando Abril Martorell, 106, recommendations can be expected. 46026 València, Spain Eleni Bakoula, Marianna Chatzikonstantinou – Fresh Line We developed a method for modelling personalised Company, 1st Klm Lavriou Ave, Koropiou–Markopoulou, dietary recommendations. The method is applied 19400, Koropi, Attica, Greece to estimate optimised fish intake in Denmark, taking into account maximum levels of chemical Microalgae biomass represents a rich source for contaminants and minimum levels of nutrients in discovery. The potential for algae-based ingredients different fish species. in the industry relies on the manipulation and targeting of ingredients to fit increasingly niche A mathematical optimisation model that applies product specifications. Algae are exposed to quadratic programming was used to model extreme environment and so have developed personalised fish intake recommendations that unique mechanism for protection. Furthermore, deviate as little as possible from observed individual algae produce for the same reason different fish intake. Model constraints ensure that modelled metabolites which we need to identify and exploit in intake levels meet the general recommendations

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for eicosapentaenoic acid (EPA), docosahexaenoic determination by ICP-MS – the levels of iodine in acid (DHA), and vitamin D without violating the the most consumed brands of cow’s milk for sale in tolerable intake recommendations for methyl Portugal, Spain, France, Italy, Germany, Poland, UK mercury, dioxins and dioxin-like polychlorinated are being determined. Results will be presented in biphenyls. Recommendations for 11 fish species were the present communication. generated for each individual in a group of 3,016 References Danish adults, whose fish intakes and body weights [1] EFSA, 2014. Scientific Opinion on dietary reference values for were recorded in a national dietary survey. iodine. EFSA Journal 2014;12(5):3660, 57 pp. Our results suggest that 55% of the study population [2] Andersson M, Karumbunathan V and Zimmermann MB, should be recommended to increase their intake 2012. Global iodine status in 2011 and trends over the past decade. Journal of Nutrition, 142, 744–750. of fish with up to 184 g/week (24% with more than [3] Zimmermann MB and Andersson M, 2011. Prevalence of 100 g/week) and that 2% should be recommended iodine deficiency in Europe in 2010. Annales d’Endocrinologie, to decrease their fish intake. 72, 164–166. Our method is appropriate for translating [4] Flachowsky G, et al., 2014. Influencing factors on iodine content of cow milk. Eur J Nutr.; 53:351–65. recommendations for single nutrients and contaminates into personalised dietary recommendations, thanks to its multidimensional property. The method has great potential for 193. Epigenetic changes induced by evolving dietary guidelines by accounting for docosahexaenoic acid on breast cancer cells personal preference, and it can also be extended to include economy and sustainability. POP Sevinci Victor Babes National Institute of Pathology, Bucharest, Romania 192. Iodine levels in cow’s milk: a survey Emilia Manole – Victor Babes National Institute of of milk from several European countries Pathology, Bucharest, Romani; Maria Kamerzan Crina – S.C. Sanimed International Impex PINTO, Edgar SRL, Bucharest Romania FFUP Isabela Tarcomnicu – SC Cromatec Plus SRL, Bucharest Romania Isabel Ferreira, Agostinho Almeida – FFUP Cristiana Tanase – Victor Babes National Institute of Iodine is an essential micronutrient for mammals, Pathology, Bucharest, Romania required for the synthesis of the thyroid hormones Docosahexaenoic acid (DHA) is an omega‑3 fatty triiodothyronine (T ) and thyroxine (T ), key effectors 3 4 acid derived from fish oil that has been associated in metabolism regulation. In fetuses and infants, with multiple benefits for human health, including these hormones play a key role in the adequate antitumor properties. Epidemiological evidence growth, development and maturation of many strongly links fish oil consumption with reduce target tissues, namely the skeleton and central incidence of several types of cancer including breast nervous system [1]. cancer. The bioactive nutrients such as DHA can According to WHO, iodine deficiency is the leading reverse the epigenetic marks that are associated with preventable global cause of mental illness and cancer initiation and development. Experimentally, development disorders [2]. In 2011, about 44% of the DHA can reduce proliferation, induce apoptosis and European population had insufficient iodine intakes. decrease invasive potential of breast cancer cells. Although iodine deficiency has been reducing over Recently, several studies have demonstrated the ability the last years through the efficient application of the of DHA to act like epigenetic modulator on global or universal salt iodisation programmes, insufficient local DNA methylation profile in cancer cells. Besides iodine intakes remain a public health problem in DNA methylation, the histone post-translational some European countries [3]. modifications are part of epigenetic mechanism involved in gene expression regulation. The degree Daily iodine requirements vary throughout the life of acetylation/deacetylation or methylation/ cycle from 40 µg/day at birth to 150 µg/day daily demethylation of lysine residues (K) within the in adulthood. Pregnant and lactating women N-terminal tail from histone H3 and H4 mark the have increased needs (175 µg/day and 200 µg/day, activation or silencing of gene transcription. In human respectively) [1]. cancer the loss of acetylation at K16 and trimethylation Cow’s milk is an important source of iodine in at K20 of histone H4 are common hallmarks. western diets. The concentration of iodine in milk Here we have analysed the effect of prolong depends on several factors, namely the iodine DHA treatment on epigenetic modification content of feed, iodine source, farm management, at histone H3 and H4 in breast cancer cell line teat dipping with iodine-containing substances, and (MCF-7) in comparison with non-tumour cell milk processing in the dairy [4] line (MCF-12A). Specific H3 and H4 modifications This study aimed to determine the iodine levels were detected and analysed by enzyme-linked in cow’s milk from different origins (i.e. countries). immunosorbent assay (ELISA) like multiplex assay. Using a validated analytical procedure – alkaline Immunofluorescence and western blot experiments digestion of the samples with TMAH and iodine were used to investigate the degree of acetylation

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at histone H4K16, H3K9, trimethylation at H3K9 and literature (Deliens, Clarys, Bourdeaudhuij and H4K20. DHA treatment induced a high degree of Deforche, 2014) to identify the key questions for the hyperacetylation at H4K16 and hypermethylation research problem (eating habits, physical activity at H4K20me3 for MCF-7 cells in comparison with levels and weight change). MCF-12A. This study highlights the capacity of a Projective techniques have been used to understand bioactive nutrient (DHA) to modulate epigenetic better emotional connections and cognitions alterations in breast cancer cell lines demonstrating towards the topic of interest (Mesías and Escribano, its therapeutic potential. 2018). According to the literature (Bloor et al., 2001), Funding the researchers reviewed the transcript encoding This work has been supported by Ministry of Research and and classified the text (using NVivo 11 plus software). Innovation (MCI), Programme POC Axis 1 Action 1.2.3. grant ID An ecological model has been developed using as P_40_197, Contract no. 52/05.09.2016 factors: individual (intrapersonal), social environment (interpersonal), physical environment (community settings), macroenvironment and an additional 194. New food habits in Romanian level of students’ attributes. Finally, ideas and population – an extensive study recommendations to facilitate the development of effective and tailored intervention programmes or environmental modifications that support healthy ROTARESCU Violeta Stefania eating have been proposed. This study, which is University of Bucharest part of a European project Marie Skłodowska-Curie Action (MSCA) ‘CONSUMEHealth’, investigates the In the modern era, basic patterns like feeding relationship between consumers and healthy eating have suffered major changes. Many researchers habits and changes in life course. connect these changes to the increased incidence of chronic or lethal diseases such as cancer. My survey put together questionnaires regarding feeding habits in families, adolescents, and a list of 196. Risk assessments of ‘other substances’ detailed analyses of the type and quantity of food in food supplements and energy drinks consumed by a whole family in a certain period on the Norwegian market of time, for the number of N = 282 families. All the data were analysed and compared with data from STEFFENSEN Inger-Lise other research and studies. Results showed a large Scientific Panel on Food Additives, Flavourings, Processing change in the feeding habits for adolescences (fast Aids, Materials in Contact with Food and Cosmetics, food preferences, variable feeding schedule) and Scientific Panel on Nutrition, Dietetic Products, Novel Food for the whole family (more processed meat, less and Allergy, Norwegian Scientific Committee for Food and vegetables etc.), compared with previous studies Environment (VKM) and recommendations in the literature. Some considerations on the correlations between feeding habits and increasing incidence of disease are made. The Norwegian Scientific Committee for Food and Environment (VKM) have, on request from the Norwegian Food Safety Authority, performed 44 risk assessments of ‘other substances’ in 2015–2017. 195. A Marie Curie project on healthy ‘Other substances’ are defined as substances eating behaviour: a case study among with a nutritional or physiological effect that are college students not vitamins and minerals, according to Directive 2002/46/EC. These substances are used in food supplements, energy drinks and sports products, SOGARI Giovanni and comprise a variety of chemical substances. They University of Parma may be botanicals, for instance caffeine, piperine Cristina Mora – University of Parma and curcumin and they may occur in regular foods. Others are found in the body naturally, such as Overweight and obesity rates have dramatically coenzyme Q10, carnithine and choline, but may still increased over the past decades in the United States be harmful if consumed in too high amounts. There and especially in the young adult population, aged have been incidents of serious health problems, between of 18 and 29, the incidence rate is the e.g. liver failure, from intake of food supplements. highest (Gordon et al., 2004; Flegal et al. 2010). These risk assessments were based on an approach According to literature (Crombie et al., 2009; Vella-Zarb established by VKM. As these substances are and Elgar, 2008; Racette et al., 2008), the university produced naturally in the body and occur in food, period is critical for young adults regarding food most of the available literature is on positive effects. choices and the relationship with weight gain. Therefore, sufficient toxicity data are often lacking. The recommended doses of the products sold on Six focus group discussions have been conducted the Norwegian market as given by the producers until saturation of new information was reached. The and/or importers were evaluated for safety, using final sample consisted of 33 students (22 women information from previous risk assessments from and 11 men) from a variety of study disciplines and the European Food Safety Authority (EFSA) and different college years. A semi-structured question other risk assessment institutions and scientific guide was developed starting with the appropriate

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publications found by literature searches. Some such are several clinical trials addressing the relationship substances were found to be of potential health risk between gut microbiota and central nervous for one or several groups of consumers (among adult system psychiatric disorders and at least one men and women, adolescents and children down to directly investigating whether there is a correlation the age of 3 years). Within the EU and the European between the composition of the gut microbiome, Economic Area, ‘other substances’ remain largely permeability of the intestinal barrier and systemic unregulated. To ensure safe use of ‘other substances’, inflammation in patients with dementia. This some countries have therefore established a national chapter discusses evidence-based data on positive regulation of these substances. These risk assessments modulation of the gut–brain axis to alleviate performed by VKM will be the basis for a national behaviour and cognition alterations in the elderly. regulation in Norway.

198. A 10-year monitoring of allergens in 197. Nutraceuticals role in modulation foodstuffs in Cyprus of gut–brain axis in elderly people VARNAVA-TELLO Antri TANASE Cristiana Laboratory of Molecular Biology and Immunology in Food, Victor Babes National Institute of Pathology State General Laboratory, Cyprus

Ana-Maria Enciu – Victor Babes National Institute of Andria Deliyianni, Elena Odiatou, Krinoula Efstathiou – Pathology, Bucharest, Romania; Carol Davila University of Laboratory of Molecular Biology and Immunology in Food, Medicine and Pharmacy, Bucharest, Romania State General Laboratory, Cyprus Elena Codrici, Simona Mihai, Emilia Manole, Sevinci Pop, Eleonora Codorean – Victor Babes National Institute of According to the World Allergy Organisation, Pathology, Bucharest, Romania even traces of undeclared allergens can cause an Cristina Mariana Niculite – Victor Babes National Institute allergic reaction to certain individuals. Currently, of Pathology, Bucharest, Romania; Carol Davila University there are 14 categories of substances or products of Medicine and Pharmacy, Bucharest, Romania causing allergies or intolerances covered by the Laura Necula – Stefan S Nicolau Institute of Virology, EU legislation (1169/2011). However there are no Bucharest, Romania legislative concentration limits covering their Isabela Tarcomnicu – SC Cromatec Plus SRL Bucharest, presence in food. Romania Over the last 10 years (2008–2017), 2,773 food A rather new and somewhat unusual concept samples (local and international), taken from retail connects brain functions to gut microbiota. It is stores and import warehouses in Cyprus, were called the ‘gut–brain axis’ (or ‘microbiota–gut–brain analysed with enzyme-linked immunosorbent axis’) and states that probiotics consumption and assay (ELISA) or real-time PCR to detect allergens. a healthy gut microbiota positively influence brain The number of samples that contained an allergen functions related to behaviour and cognition. This (protein or DNA) above the limit of quantification, concept is even more intriguing when regarded without the relevant labelling, was 196 (7.1%). An from the perspective of blood–brain barrier, which additional 47 samples (1.7%), contained the allergen was supposed to isolate the central nervous system in concentrations higher than the limit of detection from peripheral influences and to control and direct and lower than the limit of quantification, according the traffic of selected mediators in and out of the to the validation of the method used. The most brain. This barrier is, however, altered in ageing frequent undeclared allergen in the tested samples by multiple factors, from hypercholesterolemia was milk protein, followed by tree nuts (almond, and hypertension to cerebral amyloidopathy. hazelnut, walnut and pistachio) and peanuts. Synergistic with a low chronic grade peripheral Our results declare the presence of a significant inflammation, this faulty barrier exposes the aged number of food samples containing undeclared brain to negative extra-cerebral signals. Given allergens in the EU market, so posing a risk to the quasi-constant failure of pharmacological consumers’ health. This highlights the need for a treatments in neurodegenerative diseases, increased harmonised policy on the methodology and risk interest is directed towards allopathic medicine, assessment for food allergens in EU, in an effort to including dietary supplements. Currently, there is an eliminate the problems caused to the consumers, increasing amounts of evidence that nutraceuticals, authorities and food businesses. mostly those with anti-inflammatory action, are protective against blood–brain barrier alteration and against neuroinflammation itself. But most recently interplay between gut microbiota and the central nervous system by immune, neural and metabolic pathways is being explored as a possible modulator of cognitive impairment and behaviour disorders. In elderly people, this axis has been reported to be altered, contributing to systemic inflammation and was also indicated as a possible marker for early frailty in the younger population. Currently, there

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199. Use of biomarkers in the setting 200. Safety assessment of genetically of dietary reference values (DRVs) modified brown rice in the nutritional for micronutrients – experience deriving compositions through multiple statistical from recent revisions analysis

VERVERIS Ermolaos YOUNSUNG Cho EFSA Seungyong, Ra (Rural Development Administration)

Agnes de Sesmaisons-Lecarré – Scientific Evaluation of Younsung Cho, Seonwoo Oh, Seonggon Lee, Hyunsuk Regulated Products Dept, EFSA Cho, National Academy of Agricultural Science, Rural Celine Dumas, Lucia Fabiani – Nutrition Unit, Scientific Development Administration Evaluation of Regulated Products Dept, EFSA Safety assessment of genetically modified GM Androniki Naska – National and Kapodistrian University of Athens, Greece rice, which were OsCk1 (disease resistant), Agb0102 (resveratrol synthase), and Agb0103 (drought- Monika Neuhäuser-Berthold – Institute of Nutritional Science, Justus Liebig Univ, Giessen, Germany tolerant) was conducted by comparing nutrients, antinutrient and phenolic compound equivalences Dominique Turck – Division of Gastrenterology, Hepatology & Nutrition, Dept of Paediatrics, University of Lille, France with their non-GM comparators and reference commercial rice. The analysed components for The European Commission requested the European OsCK1 were proximate, amino acids, minerals, fatty Food Safety Authority (EFSA) to update the DRVs acids, vitamins, and. Phytic acid, trypsin inhibitors, established by the Scientific Committee on Food in and phenolic acids of Agb0102 and Agb0103 were 1993. DRVs are evidence-based reference values for the analysed to identify the biological equivalences with nutrient intake of healthy populations. We present an their non-GM comparators and the impacts of GM approach for setting DRVs for micronutrients for adults and the environment. The analytical tools used were based on the use of biomarkers. principal component analysis (PCA), and hierarchical clustering analysis (HCA) with Pearson’s correlation Biomarkers can refer to the levels in biological analysis. The GM rice varieties were biologically and specimens of a nutrient, its metabolites, or enzymes substantially equivalent in all of the nutrients and and cofactors involved in biochemical activities, and antinutrients evaluated. Statistical analysis showed can indicate nutrient intake, metabolism of dietary that the proximate, amino acid, mineral, vitamin constituents or nutritional status. and antinutrient components were not biologically Appraising new scientific evidence to set DRVs, EFSA different between OsCk1 and non-GM rice. The PCA reviewed for each vitamin and mineral the dose– results of phytic acid and trypsin inhibitors revealed response relationship between nutrient intakes and no clear separation among rice varieties due to biomarkers, and the relationship between biomarkers breeding conditions, environmental conditions or and health outcomes. Biomarkers were selected among the various cultivars. The phenolic acids as indicators for setting DRVs for vitamins D and were not separated clearly and overlapped in the environmental conditions and different cultivars, B6, folate, riboflavin, cobalamin, niacin, thiamin and selenium. For example, the levelling off of plasma respectively. The Pearson correlation and HCA selenoprotein P concentration was selected to analysis showed strong relationship between GMO indicate adequate supply of selenium to body tissues and non-GMO. These results indicated that the and saturation of the functional selenium body pool. contents of antinutrient and phenolic compounds Serum 25(OH)D concentration, reflecting the amount of the GM rice were not different from those of their of vitamin D from cutaneous synthesis and dietary non-GM comparators. sources, was used as a biomarker of vitamin D status and of vitamin D intake in populations with low exposure to UV-B irradiation, and evidence showed Where science meets society an increased risk of adverse health outcomes at 25(OH)D concentrations below 50 nmol/L. Barriers to the use of biomarkers included lack 201. Communication inside Risk of validation, lack of standardised protocol for Assessment and Risk Management collection and storage, or no/unclear dose–response (COMRISK) relationship between biomarker and nutrient intake/ nutrient status/health outcome. Less attention has also been paid to the evaluation of their ANDERSSON Gunnar reproducibility and sensitivity in detecting changes National Veterinary Institute, SVA in intakes and over time. Anneluise Mader – The German Federal Institute for Risk Development and improvement of biomarkers Assessment and relevant analytical methods may gradually Pirkko Touminen – Finnish Food Safety Authority contribute to new/more robust approaches to reflect Ine van der Fels-Klerx – Wageningen University intake or status for certain micronutrients, and to be used to set DRVs. The goal of the COMRISK project is to identify current practices and challenges in communication between risk assessors and risk managers and

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so increase the understanding of the interaction Moving towards mostly vegetable-based diets brings between risk assessing and risk managing several environmental and human and animal health organisations. The main question is ‘How can we benefits while being a fundamental action to meet make a risk assessment that helps the risk managers future challenges on food security and European and to make an informed decision, balancing risk and international environmental sustainability targets benefits associated with feeds and foods without such as those set by the EU 7th Environmental Action telling them what decision to take?’. Program and by the UN Sustainable Development Goals. The project is structured in different phases: startup, collection, synthesis and reporting phase. The authors suggests EFSA to perform a systematic In addition, four tasks were defined including review of all recent studies and evidence to establish horizontal activities (0), and vertical tasks like an EFSA opinion on the risks associated with the risk assessment in current decision-making (1), consumption and production of meat and other management strategies in risk assessment (2) as animal products on human health, animal health well as interaction between risk assessment and and the environment and to take appropriate steps risk management – regulation, policy, agreements, to inform the general public of the nature of these culture and tools (3). Related to these tasks, risks, including health risk as provided by article 10 relevant data will be extracted and used to set up of the General Food Law. Furthermore, EFSA could a questionnaire that will be the basis for interviews include environmental concerns in dietary guidelines with experts in the field of risk assessment and risk and develop science based sustainable diets management. Each interview will target questions recommendations. from all three vertical tasks. Results are intended to According to the strategy objective “Create an give an overview of the practical implementation of environment and culture that reflects EFSA’s values”, regulations and policies, and the agreements and EFSA could actively engage into raising awareness culture prevalent within each body. among staff and experts over the impacts that current As an outcome we expect that good practices and dietary choices have on human health and on the challenges in communication of risk assessment environment and use food sustainability guidelines results to risk managers will be identified to improve when organizing events and outsourcing catering the process of risk analysis within Europe. In services. addition, it is our intention to follow up the project Evolving towards the establishment of a European with future grant applications. Food Sustainability Authority and challenging the The consortium of this EFSA Partnering Grant current major crisis, not only on the basis of societal (GP/EFSA/AFSCO/2017/01–GA05) is composed expectations and values, but on the solid and extensive of experienced institutions including partners available scientific evidence, is what could be truly from four different European countries: National called “contextualising risk assessment”, “advancing Veterinary Institute (SVA, Sweden, Coordinator), The risk assessment science” and “staying relevant in a German Federal Institute for Risk Assessment (BfR), changing world”, the themes of this year conference. Finnish Food Safety Authority (EVIRA), Wageningen University (WU, the Netherlands). The project started in January 2018 and will run for 2 years. 203. Dietary exposure uncertainties mapping

202. Based on current legislation should COLEMAN Sinead meat be banned? ILSI Europe, Belgium/Cork Institute of Technology, Ireland

David Tennant –Food Chemical Risk Analysis, UK CHRISTOPH Eugen H. Diána Bánáti –ILSI Europe, Belgium Independent expert Marc Kennedy –FERA, UK Francesca Riolo – Independent expert Jürgen König –University of Vienna, Austria Cian O´Mahony –CREME, Ireland This provocative poster highlights selected scientific evidence available on the impact of meat production Susanne Kettler –Wrigley GmbH, Germany and consumption on human and animal health and Uncertainty analysis is a vital component of the environment, making meat qualifying for being dietary exposure assessment, which is necessary a food that “is likely to constitute a serious risk to to understand the strengths and limitations of human health, animal health or the environment” for the results. However, the sources and types of which, according to current legislation (e.g. article 53 uncertainties in deterministic and probabilistic of Regulation (EC) 178/2002), one or more restricting exposure models can vary widely. We present a measures including the suspension of the placing on method for mapping different sources and types the market or use of the food in question could be of uncertainties to better describe uncertainty adopted. analyses and to generate a more realistic Scientific evidence indicates that meat consumption understanding of dietary exposures. Parameter and production could constitute a serious risk to and model uncertainties are identified for each human health, animal health and the environment. modelling approach (from a simple deterministic and to a more sophisticated probabilistic exposure

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assessment). The relative importance of each source of 205. Methodology to evaluate pesticide uncertainty is then evaluated using a semi-quantitative active substances for the essential scale and the results expressed using different forms of control of a serious danger to plant graphical representation. The value of this approach in expressing uncertainties in a manner that is relevant and health useful to risk managers and the wider public is discussed. ERDOS Zoltan EFSA

204. Uncertainty communication – Fernando Álvarez-Alfageme, Ciro Gardi, Christina EFSA’s approach to communicating Riemenschneider, Claudia Heppner – EFSA scientific uncertainties in food safety *The positions and opinions presented in this poster assessments are those of the authors and are not intended to represent the views or scientific works of EFSA. DA CRUZ Cristina In the European Union the evaluation of active European Food Safety Authority (EFSA), Parma, Italy substances (a.s.) used in plant protection products Andy Hart – Newcastle University, UK (PPP), and their residues in food and feed is Laura Maxim – Centre National de la Recherche regulated and follows a comprehensive process with Scientifique (CNRS), France responsibilities of risk assessors in Member States Caroline Merten – EFSA, Parma, Italy (MSs), the European Food Safety Authority (EFSA), Olaf Mosbach-Shulz – EFSA, Parma, Italy and risk managers in the European Commission (EC) and MSs. Michael Siegrist – ETH Zurich, Switzerland Anthony Smith – EFSA, Parma, Italy The objective of the risk assessment is concluding Majlinda Lahaniatis – EFSA, Parma, Italy whether the a.s. can be expected to meet the approval criteria in Article 4 of Regulation (EC) No. Natalie von Götz – ETH Zurich, Switzerland 1107/2009. A request of derogation can be requested Anthony Hardy – EFSA Scientific Committee Parma, Italy by applicants and/or MSs in specific cases i.e. (1) Communicating scientific uncertainties is an under Article 4(7) (approval of substances which important component of EFSA’s broader practices are so essential but may be non-approved, even if of risk assessment and risk communication. there is an acceptable risk assessment); or (2) under EFSA communicates the results of its scientific Article 53 (emergency authorisations of PPP due to assessments to decision-makers, stakeholders a danger which cannot be contained by any other (e.g. safety risk managers, assessors, consumer/ reasonable means). non-governmental organisations, media, food The EC requested EFSA to develop a methodology chain businesses) and the public at large. A clear for the evaluation of data on the necessity of and unambiguous communication of scientific the application of herbicides, insecticides and uncertainty helps them to understand the range fungicides a.s. to control a serious danger to and likelihood of possible consequences, and acts plant health that cannot be contained by other as an enabling mechanism providing scientific available means, including non-chemical methods. grounds for risk-based decision-making. While EFSA delivered three protocols, proposing a developing its ‘Guidance on Uncertainty Analysis in harmonised methodology for the evaluation of Scientific Assessments, EFSA’s Scientific Committee the request of derogation. The methodology is recommended EFSA to develop further guidance based on: (1) alternative a.s. and risk of resistance; on communication. The resulting ‘Guidance (2) non-chemical alternatives; and (3) resistance on Communication of Uncertainty in Scientific management scores. Assessments’ here presented contains general recommendations for communicating uncertainty Since 2016, EFSA has evaluated the request of and specific advice on how to communicate derogation for six a.s. (flumioxazin, flupyrsulfuron- the various expressions of uncertainty produced methyl, isoxaflutole, pymetrozine, bromoxynil by the methods described in the ‘Guidance on and thiacloprid) under Article 4(7). To date EC Uncertainty Analysis in Scientific Assessments’. did not grant an approval under this provision. Such recommendations are tailored according to In 2018 EFSA applied the Article 4(7) insecticide EFSA’s three categories of target audience–‘entry’, protocol to evaluate whether Article 53 emergency ‘informed’ and ‘technical’. The key evidence sources authorisations granted by several MSs for three include an expert analysis of selected academic neonicotinoids were scientifically supported. literature, extracts from frameworks or documents similar in scope and purpose from other advisory bodies, and the results of EFSA target research – a focus group study and an online survey carried out in six languages and eight EU countries. Expertise in social sciences, scientific assessment and communications were vital to set down this approach to aid risk communicators at EFSA, but which can also be applied by risk communicators working in the food safety, public health and related areas.

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206. Food innovation requires transparency 207. Building a framework to help define a and efficiency in risk assessment tolerable risk in food allergy

KOSTOLANIOVA Petra MADSEN Charlotte Bernhard EuropaBio National Food Institute, Technical University of Denmark Elisa Cavandoli – Barilla G&R Fratelli, IT Strengthening of public trust in the EU risk Chun-Han Chan – Food Standards Agency (FSA), UK assessment model requires a holistic approach, Stella Cochrane – Unilever, UK which aims at ensuring the sustainability, efficiency Elise Hoek – Danone Food Safety Centre, NL and transparency of the risk assessment in the food Geert Houben – The Netherlands Organisation for Applied and feed chain. Consistent science-based decision- Scientific Research (TNO), NL making by risk managers along with improved risk Rebecca Knibb – Aston University, UK communications by the European Commission, the EU Member States and EFSA would contribute to André Knulst – University Medical Centre Utrecht, NL; Marsaux, Cyril, ILSI Europe, BE enhance public trust in the current system. Stefan Ronsmans – The Coca-Cola Company, BE To increase public confidence, the public demand Sabine Schnadt – German Allergy and Asthma Association for more transparency needs to be embraced by (DAAB), DE all players and across all processes. A balanced Frans Timmermans – European Anaphylaxis Taskforce, NL approach to transparency requires a mechanism Paul Turner – Imperial College London, UK for disclosure of information, which ensures the Myrthe van den Dungen – DSM, CH protection of legitimate private and public interests, including innovation and competitiveness. Ross Yarham – Food Standards Agency (FSA), UK René Crevel – René Crevel Consulting Limited, UK Sustainability of the EU risk assessment model also necessitates a mechanism to attract the best Tolerable risk links risk assessment and risk expertise in EFSA to guarantee continuity and inmanagement, driving the necessary measures depth understanding of the risk assessment principles. to ensure that risk management objectives Stakeholder consultations during the development are attained. Yet, while risk assessment and of EFSA mandates and pre-submission activities for management measures are intensely debated, obtaining scientific advice from EFSA would enhance formulation of food allergy risk lacks clarity and the the quality of product applications as well as the level rationale and values underlying decisions about of engagement of society. tolerable risk are often not explicit. This lack of clarity has significantly affected definition of appropriate Effective communication addressing the broad risk benchmarks for food allergens, hindering public is essential. Improved communication improvements in their management. To address should highlight the integrity and quality of this issue, the ILSI Europe Food Allergy Task Force EFSA’s Scientific Opinions in a manner that is has assembled a multistakeholder Expert Group to understandable for the general audience. Major investigate a potential framework to make definition strengths of the current system, which is the most of tolerable risk clearer and more consensual. This rigorous in the world, like adherence to EU and project will identify participants in the framework international guidelines for conduct of scientific (expertise, stakeholders) as well as what parameters studies, independence of the EFSA review and the framework will need to consider. Together quality systems under independent control, need to with risk assessment scientists from academia, be proactively explained and communicated to EU industry and government, food allergy clinicians citizens. The European Commission and other EU and psychologists, the Expert Group includes institutions should address the spread and sources representatives of those most closely affected, i.e. of misinformation that undermine science-based people with food allergies. Successful development risk assessment and the credibility of EFSA. and implementation of such a framework in food allergy could also point to applications in other areas of food safety, and helping to promote greater trust in food safety assurance.

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208. On ‘fakebook science’ and Such a dubious course of action is allegedly based on democracy a pillar of our democratic framework: it is maintained that, when a great number of people express their TAGLIABUE Giovanni preference for certain options, their will must be Independent researcher followed. But this conviction reveals a deep lack of understanding of what democracy is: basic values are not dependent on the variable moods of the The 2018 EFSA Conference is on ‘Science, Food, public, but are established and rooted in constitutions. Society’; the main theme of the first day is ‘Where The majority rule is a necessary, but not sufficient, science meets society: putting risk assessment in condition of democratic collective choices. context’. It is claimed that ‘values are becoming more influential than facts in shaping public opinion’ In this sense, not all ‘values’ are equal: decision- and ‘risk managers need to balance facts and values makers should have the constitutional principles as effectively’. Therefore, we are in need of ‘restoring the a constant reference. Consider the two situations credibility of and trust in risk assessment, by placing mentioned above: most life scientists have always it in a societal context’. pointed out that the biotech processes used to create agricultural novelties have no relevance These statements are problematic, in that they for the evaluation of the outcomes, and therefore seem to oppose ‘facts’ to ‘values’. In discussing such any sectarian regulation for ‘GMOs’ is unjustified; possible confusion, I will make a few points: as for glyphosate, almost all the international The concept of evidence, with relation to the organisations which oversee the safety of chemicals base of data and science-informed analyses (risk (EFSA, FAO+WHO, ECHA, EPA) concluded that the assessment) that should guide the outlines of product is relatively benign. Following those science- policies to be implemented (risk management), informed risk assessments, risk managers should is contentious. Yet, many experts still think that, not have any doubt about legitimate authorisations. once the due dose of humility has been applied In any such case, the principle to be preserved is the in recognising the limits of our knowledge and of economic freedom of a fairly regulated market – one the tools we use to investigate reality, the search cherished value in democracies. for objective truths remains the necessary premise to good policy decisions. The insistence of some scholars (mostly sociologists) in warning that 209. Exploring a future model for the scientific results – particularly in risk assessment – are always value-laden, or even biased, may drive scientific risk assessment of pesticides us down the slippery slope of total relativism: worse than being an oxymoron, that position is logically TARAZONA Jose contradictory. Therefore, a rational and healthy EFSA Pesticides Unit distinction between facts and values is to be reaffirmed and buttressed. Based on internal reflections and dedicated The search for evidence must follow scientific consultations with the EFSA Pesticides Steering guidelines: the risk assessment should not Network (PSN) and the PPR Panel, the poster will be influenced by the moving tides of public explore the possibility of extending the scientific opinion. EFSA’s chief, Dr Bernhard Url, warned risk assessment at EU level, to include also of the about ‘Facebook science’ (www.youtube.com/ scientific assessment of plant protection products watch?v = ivQ0Ph9OWZU&feature = youtu.be), i.e. (PPP). The separation between risk assessment and the untenable belief that risk managers (political risk management and the direct involvement of decision-makers) should be offered evaluations the network of Member State (MS) risk assessment that are carved out according to demands coming organisations coordinated by EFSA are key strengths from sectors of society, frequently supported by to be maintained. In addition, some scientific and online petitions. Moreover, those referenda may technical assessments such as efficacy or integration be deceitful, as they often rely on fake news and of plant protection alternatives for ensuring ‘alternative facts’: since internet websites and social sustainable use are better suited for national networks are too often sources of misinformation, I evaluations; while risks to human health and the propose to call this phenomenon ‘fakebook science’. environment could be efficiently covered at EU level using landscape considerations supported by Indeed, politicians who are looking for easy consensus spatially explicit tools. can elect to put aside a sound scientific approach and follow the groundless stances of influential For dietary risk assessments, Regulation (EC) No. pressure groups: risk managers may voluntarily 396/2005 already requires harmonised scientific argue against risk assessors. Two sad examples are assessments at EU level covering all uses, as well as the prevalent unscientific regulation of so-called specific provisions for updating the risk assessment Genetically Modified Organisms in most countries to account for the authorised uses of PPPs by and the recent debate about the re-authorisation of the MS. The proposal focuses on the pre-market the herbicide glyphosate in the European Union. In scientific review process described under Regulation these cases, office-holders decided either to ignore or (EC) No. 1107/2009 focusing on options for extending to question the overwhelming scientific consensus. both concepts – meaning an EU assessment of all This opportunistic behaviour is called demagoguery by uses and an update of the risk according to the MS political scientists. authorisations – to the non-dietary human health

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assessments and to environmental risks. Innovative ways for addressing the zonal and regional variability within a single but spatially explicit assessment at EU level are proposed; those could cover the environmental assessments as well as non-dietary risks for workers, residents and bystanders. A key driver is to produce pesticides risk assessment outcomes relevant not only for decision-makers at EU and MS level, but also for farmers, practitioners and citizens in general.

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