DIE AKADEMIE FRESENIUS Where Experts Meet!

Highlights

Regulatory Aspects

• ECHA’scurrentactivitesregardingbiocides• GermanBfRonbiocideresiduelevelsinfood

–authorityguidancedevelopment• DutchCtgbonUnionAuthorisation–over-

viewofstatusandreviewofbestpractices• DanishEPAonBiocidalProductFamilies• Endocrinedisruption:Industryviewonthe

statusofdevelopment

Specific Regulatory Areas

• ECHAEnforcementForum:EnforcementundertheBPR

• Reapprovalsofsubstances–authorityperspective

Current Legal Challenges

• Brexit:Implicationsfortheregulationofbiocides

• Innovationandsustainableusesofbiocides• Datadevelopment:Globaldataforever

regionalizedmarkets

Market Developments

• OverviewofActonSafetyManagement:ConsumerchemicalproductsandbiocidesundertheKoreanBPR(K-BPR)

• Innovationandsustainableuseofbiocides

The Experts

Darren Abrahams Steptoe&Johnson | Andrew Adams Bayer | Eugen Anwander ECHAEnforcementForum/VorarlbergInstitutefortheEnvironment | Samantha Champ BASF | Flore Cognat EuropeanChemicalIndustryCouncil(CEFIC) | David Dillon ExponentInternational| Coen Graven Dutch NationalInstituteforPublicHealthandtheEnvironment(RIVM) | Marcel Hulsman DutchBoardfortheAuthorisationofPlantProtectionProductsandBiocides(Ctgb) | Hyunpyo Jeon KoreaInstituteofScienceandTechnology | Alfonso Las Heras EuropeanCommission| Anne Munch Christensen DanishEnvironmentalProtectionAgency|Rodolphe Quérou DOWTheChemicalCompany| Laura Ruggeri EuropeanChemicalsAgency (ECHA)| Christian Stallberg NOVACOS Law | Anke Visan GermanFederalInstituteforRiskAssessment(BfR) | Michelle Whelan Irish DepartmentofAgriculture,FoodandtheMarine(DAFM)

28 February and 1 March 2018 in Mainz/Germany

The Biocidal Products Regulation

17th International Fresenius Conference

Updated Programme

Attheendofthefirstconferenceday,AkademieFreseniusinvitesyoutoaleisurelyeveninginthelocalwinegrowingregion.EnjoyawinetastingandagreatmealatthechampagnecellarsofthewineryFlickandcontinuetheday‘snetworkingactivitiesinarelaxedatmosphere.

Wednesday,28February2018

8.30 Registration and coffee

9.00 Welcome address by the organisers and intro-duction by the Chair

Samantha Champ, BASF,Germany

Regulatory Aspects9.10 Update from the European Commission

Alfonso Las Heras, EuropeanCommsission,Belgium

9.40 ECHA’s current activities regarding biocides

Laura Ruggeri, EuropeanChemicalsAgency(ECHA),Finland

10.10 Panel discussion10.40 Coffee break

11.10 Endocrine disruption – status for biocides

• Howwillcriteriabeapplied?• Thestrangecaseofbiocidalproducts• Whatabouttherest?

Andrew Adams, Bayer,France

11.40 Authority perspective on the criteria for endocrine disruption and its guidance

• Statusofguidance• Thoughtsregardingitsimpactontheactivesubstance

assessmentanditsproducts

Coen Graven, NationalInstituteforPublicHealthandtheEnvironment(RIVM),TheNetherlands

12.10 Biocide residue levels in food – current guidance developments

Anke Visan, FederalInstituteforRiskAssessment(BfR),Germany

12.40 Panel discussion13.10 Lunch

14.10 Union Authorisation – authority perspective

• Overviewofstatus• Reviewofbestpractices• Tipsandtricksforapplicants–howtomakethemost

oftheopportunity

Marcel Hulsman, BoardfortheAuthorisationofPlantProtectionProductsandBiocides(Ctgb),TheNetherlands

14.40 Biocidal product families: Uncertainties with possible combinations

• Similaruse,similarcomposition,similarlevelofriskandsimilarefficacy

• Developmentsintheworkingpartyontheimplemen-tationoftheBiocidalProductFamilyconcept

• MemberstateviewonchallengeswithBiocidalProductFamilies

Anne Munch Christensen, EnvironmentalProtectionAgency,Denmark

15.10 Panel discussion15.40 Coffee break

16.10 Brexit: Implications for the regulation of biocides

• Updateonnegotiations• Transferofapplications

Darren Abrahams, Steptoe&Johnson,Belgium

Specific Regulatory Areas16.40 Challenging renewals, industry’s views and lessons learned

• Candidatesforsubstitution• Pointstoconsiderattherenewalstage• Experiencefromrenewalofrodenticides

Flore Cognat,EuropeanChemicalIndustryCouncil(CEFIC),Belgium

17.10 Panel discussion17.40 End of the first conference day

18.50 Departure time for the evening event

Get-together on Tuesday, 27 February 2018WillyouarriveonTuesday?Cometothehotelbarat8p.m.andmeetotherparticipantsandexpertsinarelaxedatmosphere.

The Programme

Thursday,1March2018

9.00 Welcome address by the Chair

Samantha Champ, BASF,Germany

9.10 Reapprovals of substances – authority perspective

• RepeatingworkapprovedunderBPDandapplyingBPR

Michelle Whelan,DepartmentofAgriculture,FoodandtheMarine(DAFM),Ireland

9.40 Enforcement under BPR

• Scopeofwork• Activitiesandtopicsdealtwith• Plan• Responseandimplicationsofenforcement

Eugen Anwander ECHAEnforcementGroup/VorarlbergInstitutefortheEnvironment,Austria

10.10 Borderline cases and product status issues under the BPR – how to navigate through the current regulatory framework

• Whatarethemostcommondemarcationissuesinpractice?

• Howtodealwithlegaluncertaintiesinpractice?• Applicablelegalinstrumentsandbestpractices

Christian Stallberg, NOVACOSLaw,Germany

10.40 Coffee break

11.10 The Challenges of a global biocides regulation

David Dillon, ExponentInternational,UnitedKingdom

11.40 Panel discussion

Market Developments12.10 Overview of Act on Safety Management: Consumer chemical products and biocides under the Korean BPR (K-BPR)

• IntroductionofK-BPR• Obligationsofmanufacturerofconsumerchemicals

andbiocidesunderK-BPR• IssuesinlegislationofK-BPR

Hyunpyo Jeon, KoreaInstituteofScienceandTechnology,Germany

12.40 Innovation and sustainable use of biocides

• Futurelookatmarketdevelopment/needs• Requirements• Criticaloverviewoffuturedevelopmentsie.down-

streamusers

Rodolphe Quérou, DOWTheChemicalCompany,France

13.10 Final discussion13.40 Lunch and end of the conference

Informationavailableonlineat: www.akademie-fresenius.com/2505

12and13April2018inDusseldorf

6th International Fresenius Conference ”Environmental Risk Assessment of Biocides“

info@akademie-fresenius.com www.akademie-fresenius.com/2504

Darren Abrahams isanEnglishBarrister,SteptoePartnerandAvocatattheBrusselsbar.HispracticeisfocusedonEUregulatoryrequire-mentsandtherelated

commercialissuesintheenvironment,chemicalsandlifesciencesareas.

Andrew Adams collectedmanyyearsofexperienceworkinginEuropeanregulatoryaffairsforbiocides,beforemovingintoapublicandgovernmen-talaffairsroleatBayer

CropSciencein2014.Withspecificfocusonendocrinedisruptors,hecurrentlyrepresentstheECPAasChairoftheirEDExpertGroupandcontributedtotheEDHighLevelGroupinCEFIConbehalfoftheBiocidesSectorGroup.

Eugen Anwander hasbeenemployedattheFederalStateGovernmentServiceVorarlbergintheInstituteforEnviron-mentandFoodSafetyandtheChemicalSafetyUnitsince1992.HeiscurrentlytheChairoftheBiocidalProductsRegulati-onSubgroupwithintheECHAEnforce-mentForum.

Samantha Champ iscurrentlyemployedbyBASFSE,leadingtheregulatoryaffairsteamforBiocidesEurope,inthecompany’sCareChemicalsdivision.Herresponsibilitiescoverall

BPRactivities,nationalbiocideregistrationschemesandborderlinelegislationssuchascosmeticsandmedicalproducts.Since2014sheistheVice-chairoftheCEFICEuropeanBio-cidesProductForumandwillbecometheChairasof2018.

Flore Cognat joinedCEFICinNovember2013.Since2016,shehasbeenleadingseveralgroupswithintheCEFICSectorGroupofEuropeanproducersofbiocidalactive

substancesandproducts–theEuropeanBiocidalProductsForum(EBPF).Inthisposition,sheactivelyfollowstheregulatorydevelopmentsoftheEUbiocideslegislation,providingsupport,informationandadvicetoCEFICmembersintheareaofcomplianceandimplementation.

The ExpertsDavid Dillon worksatExponentInter-

national.Hisroleincludestheprovisionofstrategicregulatoryadviceandsupportforbiocides(activesubstanceapprovaland

productauthorisation).David’spreviousexperienceincludesworkingfor18yearsintheUKCompetentAuthorityforbiocidesworkingonnational,Europeanandinternationalchemicalcontrolschemesandjustunder7yearsworkingforindustry.

Coen Graven is aregisteredToxicologistandProjectLeaderatRIVM.Since2014hehasbeenworkingintheareaofBiocideandPlantprotectionproductriskassessment

andmethodologydevelopment.HeiscurrentlyalsofulfillingtheroleasExpertintheadhocECHA/EFSAEndocrineDisruptionGuidanceConsultationGroup.HehaspreviouslyworkedattheDutchcompetentauthorityCtgb.

Marcel Hulsman hasadegreeasChemicalEngineerandholdsaPhDinanalyticalchemistry.Since2013hehasbeenworkingasAccountManagerBiocidesfortheDutch

Ctgb.PriortohiscurrentpositionhegainedexperiencesasLaboratoryManagerandBusinessDevelopingManager.

Hyunpyo Jeon receivedhisPhDfromJohannes-GutenbergUniversityinMainzin2011,afterworkingatKumhoLaboratoryasSeniorResearcherinKorea.Hehasbeena

memberoftheEnvironmetalSafetyGroupofKISTEuropeForschungsgesell-schaft,whichisabranchinstituteoftheKoreaInstituteofScienceandTechnolo-gyforchemicalregulationcompliance,since2011.

Alfonso Las Heras dealswithissuesrelatedtoproductauthorisationwithintheboicidesteamofUnitE4inDGSANTÉ.Hisprofessionalbackgroundrelatesto

theregulatoryframeworkofveterinarymedicinesandtopublic-privatepartnershipforresearchonanimalhealth.

Anne Munch Christensen graduatedasEnvironmentalEngineerfromtheTechnicalUniversityofDenmark(DTU).SheholdsaPhDfromitsPharmaceuticalFacultyfocusingon

pharmaceuticalsintheenvironment,andworkswithbiocidesattheDanishEPA.

Rodolphe Quérou holdsaPhDinagronomyandenvironmentalchemistryandhasmorethan20yearsofexperienceinregulato-ryandtechnicalfieldsof

thebiocidesandagchembusiness.HeistheGlobalRegulatoryManageratDOWMicrobialControlandmemberoftheCEFICEuropeanBiocidalProductsForumManagementCommittee.

Laura Ruggeri joinedECHABiocidesAssessmentUnit´s,humanhealthteamin2013.ShehasbeentheChairoftheadhocBiocidalProductCommitteeWorking

GroupontheAssessmentofResidueTransfertoFood(ARTFood)since2014.

Christian Stallberg holdsaPhDinlawandisaPartneratNOVACOSLaw,specialisinginhealthcare,lifesciencesandchemicals.Heisalsoamemberofthe

editorialboardoftheGermanlegaljournal“ZeitschriftfürStoffrecht”andcurrentlyadvicesasubstantialnumberofGermanandinternationalenterprisesintheareasofdevelopment,marketingandsalesofchemicalsubstances,biocidesandmedicalproducts.

Anke Visan studiedbiologyandpublichealth.Since2015shehasbeenworkinginthedivisionforSafetyofPesticidesattheGermanFederalInstituteforRiskAssessment(BfR).

Michelle WhelanhasaPhDinChemistry.ShejoinedthePesticideControlDivision(PCD)oftheIrishDepartmentofAgriculture,FoodandtheMarine(DAFM)in2011.Michelleworked

co-ordinatingtheevaluationofactivesubstancesandbiocidalproductsandwastheCGmemberandalternateBPCmemberuntilsheleftthedivisionin2015.Michellere-joinedPCDin2017asthebiocidesenforcementofficerandsheisnowtheHeadoftheBiocidesEnforcementUnit.

Who do you meet?Groups that should take part:

Managingdirectors,boardsofdirectors,managers,consultantsandscientistsinthefieldsof

• Registrationandauthorisation

• Legalandregulatoryaffairs

• Researchanddevelopment

• Productsafety

• Productmanagement

• Regulatoryscience

Sectors that should take part:

• Chemicalandbiocidesindustry

• Producersofbiocidalproducts

• Industrialandprofessionalusersofbiocides

• Researchinstitutes

• Regulatoryauthorities

• Environmentalandhealthriskconsultants

• Professionalassociations

About

Organisationandparticipantmanagement

Danielle Sörries phone: +49 231 75896-74 dsoerries@akademie-fresenius.de

Do you have any questions?

Trade ExhibitionOurconferenceprovidesyouwiththeopportunityofpresentingyourcompanyinatradedisplay.Presentyourproductsandservicesandreachouttoyourspecifictargetgroups.Wewouldbehappytoprovideyouwithinformationonallthevariousoptionsavailable–fromdisplayingproductinformationtoanexhibitionstand–withnofurtherobligationonyourpart.

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Semsigül Yalcin phone: +49 231 75896-94 syalcin@akademie-fresenius.de

The OrganiserForover20years,AkademieFre-seniushasbeenyourpartnerforpractice-orientatedtrainingonallthelatesttopicssurroundingthesafetyandqualityoffood,consumergoodsandchemicalproductsalongthewholeproductionchain.Ourportfolionotonlyincludesinterna-tionalconferencesbutalsooffersnationaltrademeetings,intensivepracticalseminarsandtraininginsmallworkgroups.

Oureventsaredesignedtopromoteanactiveexchangeamongstourparticipantsandoffertheperfectplatformforbringingtheindustry,thescientificsector,theauthoritiesandtheconsultingfieldtogether.Excellentservice,all-inclusive.Ourwide-rangingadvancedtrainingopportunitiescontributetogivingourcustomersthecompetitiveedgeinallqualityassurance,riskassess-ment,legal,productionandtechni-calquestions.

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Youcanfinddetailsonupcomingandneweventsatwww.akademie-fresenius.com

Programmeandconceptualdesign

Anne Möller phone: +49 231 75896-83 amoeller@akademie-fresenius.de

Terms of Participation and PurchaseTheregistrationfeeincludestheeventparticipation,eventdocumenta-tion,lunch,coffeebreaks,beveragesaswellastheeveningevent.Youwillreceivewrittenconfirmationofyourregistration.Uponreceivingourinvoice,pleasetransfertheamountduewithoutfurtherdeductionsbeforetheeventbegins.Thepriceoftheeventdocumentationincludesahardcopyofthedocu-mentationasweIIasanaccesscodetothesecureAkademieFreseniusdownloadarea.Boththedocumentsandthesecureaccesscodewillbedispatchedaroundtwoweeksaftertheeventandassoonasadvancepaymenthasbeenreceived.

Group ReductionsForjointbookingsreceivedfromonecompanywegranta15%discountfromthethirdparticipantonwards.

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Participation Event Documentation

Trade Exhibition

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