experiences with bpf (and ua) as ecadiscussion table echa working group meeting echa ad hoc...

ExperienceswithBPF(andUA)aseCA

MarcelHulsmanCtgb AccountManagerBiocides

BPRSymposiumARCHE- pIEtBrussels,17October2017

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Firstexperiences onBPFand UA

UAand BPF:newconcepts• Firstevaluations finalised• Firstexperience onpeerreviewphase

MostUAapplicationsareBiocidalProductFamilies• EvaluationphasebasicallysimilartoNA• ComplexitydeterminedbyBPFstructure

Takehomemessages• BeawareofongoingdiscussionsonBPF• SMEconsiderjoiningaconsortium

and/orapplyviaSameBiocidalProduct• ConsultyoureCA pre-submission

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Outline

• UApre-submission,guidance and support

• UAprogress

• Outlookontheforthcoming approval of

(disinfection)active substances

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UnionAuthorisation

• AuthorisationgrantedbytheEuropeanCommission,validontheentireEUmarket

• Forsinglebiocidalproductsandproductfamilies

• Excluded:

o Productscontainingsubstancesfulfillingtheexclusioncriteria(Article5ofBPR)

o Productstocontrolrodents,birds,fish,andothervertebrates(PTs14,15,17and20)

o Antifoulingproducts(PT21)

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• Contactyour eCA for eCA-agreemento preferably atleast 1year before submission

• ContactECHAfor pre-submission procedureo Atthelatest 180days before theintended dateof

submission

• MSs and COMwill be consulted to confirm thatfortheproductandproposeduses:o falls within the scope of BPRo the appropriate product-type has been identifiedo has similar conditions of use across the Union

Pre-submission UA

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Comments (COM):• Onthe composition,the eCA should be careful onthe function

ofeach ofthe co-formulants.Contribution ofco-formulants tothe biocidal efficay?

• Various PT(2,6,11,12,13)uses.TheeCA should considerwhether those intended uses with the application areornotsimilar and whether they may be covered by the same riskandefficacy assessments,to ensure that the designofthe BPFiscorrect.

• Similar uses:wewonderwhether the PT1use can beconsidered assimilar to the other PTs (2,3,4,5).However,itshould also be balanced with the proportionality ofsubmittingaseparateapplication for this PTonly.

• Theoverview documentisvery useful.

Pre-submission Outcome examples (1)

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Comments (MSCA):• IncaseSoC will be identified inthe BPF,the availabilityofaGerman

occupational exposurelimit(OEL)and its suitability orthe riskassessmentfor workers haveto be checked.Accordingto nationalregulation the OELislegal bindingfor workplaces.

• IncaseofPT5(especially for productsfor disinfecting drinking waterfor humans),national drinking waterregulations should be takenintoaccount.

• Compositions donot include stabilizers.Stabilizers arenot mandatory.However,incasestabilizers areused,which istypical,they should belisted inthe composition.

• Itshould be considered whether surface disinfection inPT2,3,4can beconsidered as“similar use”with drinking waterdisinfection inPT5,since they would require almost completeand non-complementaryriskand efficacy assessments.

Pre-submission Outcome examples (2)

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UAApplicationand Validation

APPLICANT

eCA

Dossierevaluation

starts

Formatcheck(andfeeinvoice)

ECHA APPLICANT

FeepaymentApplicationsubmission

Feeinvoice

eCA ECHA

Applicationacceptance

eCA

Applicationvalidation

APPLICANT

Feepayment

If additional information isrequired, suspension of thevalidation period is possible,not exceeding 90 days

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eCAeCA

Dossierevaluation(365days)

PARanddraftSPCtotheapplicant

Possibilityforwritten

comments(30days)

APPLICANT

RevisionofPARanddraftSPC

eCA

Ifadditionalinformationrequired,suspensionoftheevaluationperiodnotexceeding180daysintotal

Peerreviewstarts

ECHA

UAEvaluation

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AccordancecheckPAR

ECHA MSCAs

Commentingperiod

eCA

Responsetocomments

eCA

Updatedresponsetocomments

eCA

Trilateraldiscussions

Prefilleddiscussiontable

ECHA

Workinggroupmeeting

ECHA

Adhocfollow-up

(ifnecessary)

ECHA

BPCmeeting

ECHA ECHA

BPCopinion(180days)

APPLICANT

Submissionoftranslated

SPC

COM

Authorisation

UAPeerReview

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FirstUAapplicationsenteredthepeerreviewphase:BPFbasedoniodine/PVPiodine(PT3-PT4)

2applicationsforeseenfordiscussionat:• WG-IV-2017(September2017)• BPC-23(December2017)

• 2UA-BBPslinked

UAProgress

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Firstexperiences (1)

NationalAuthorisationand MutualRecognition• Bilateral discussions• Fewformal disagreements (Coordination Group)

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Coordination Group(1)

• Participants:– CAs ofall EU-MSs (incl.CH,NO,IS)– Stakeholdersfrom Industry and NGOs– EU-Commission and ECHA

• Operational since September2013• Secretariat provided by ECHA

• Main role:Solving MutualRecognition disputes• Focusonharmonisation• Noagreement=>EU-Commission

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Coordination Group(2)

• Fewformal disagreements (butincreasing)• Disagreements aresolved based onconcensus• Generallyquickly solved• Disagreements referred to EU-Commission:6

Referrals discussed attheCG

2014 6

2015 9

2016 16

2017(to date) 32

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Firstexperiences (2)

NationalAuthorisationand MutualRecognition• Bilateral discussions• Fewformal disagreements (Coordination Group)

UnionAuthorisation:newconcept• Firstevaluations finalised• Firstexperience onpeerreviewphase

MostUAapplicationsareBiocidalProductFamilies• EvaluationphasebasicallysimilartoNA• ComplexitydeterminedbyBPFstructure

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• Ctgb publishes EvaluationManuals,technical work instructions(mainly for internal use).

• EvaluationManuals describe theassessmentframework usedby Ctgb for theevaluation ofbiocidal productapplications

• Periodically updated inaccordance with newlegislation andEUguidances

• EvaluationManuals coverBPRand National(transitional)framework

• Requirements related to national specific elements arelisted

https://english.ctgb.nl/documents/assessment-framework-biocides/2017/03/31/evaluation-manual-biocidal-products-2.0

Biocidal ProductsEvaluationManual

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Ctgb focuses onEUharmonisation,limited number ofdeviations

NLspecific elements

https://english.ctgb.nl/documents/assessment-framework-biocides/2017/03/31/evaluation-manual-biocidal-products-2.0

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Ctgb Prioritylistvalidation (1)

https://english.ctgb.nl/biocidal-products/application-process/intake-phase

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Ctgb Prioritylistvalidation (2)

https://english.ctgb.nl/biocidal-products/application-process/intake-phase

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Ctgb Prioritylistvalidation (3)

https://english.ctgb.nl/biocidal-products/application-process/intake-phase

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Samebiocidal products(SBP)• Anauthorisationissought for aproductthat isidentical

to an authorised product(=thereference product)• SMEs and privatelabelcompanies• Regulation (EU)1802/2016(October 2016)amending

regulation (EU)414/2013=>– SBPsingleproductfrom BPF– SBPnational authorisationfrom UA

Biocidal productfamilies(BPF)• Bewareofongoing EUdiscussions (size,PTs,uses)• BPFGuidance Q&Awill be updated

NewRegulations and guidance

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Topic

A Furtherclarificationoftheconceptofsimilarityapplicableto:1.composition/2.uses/3.levelsofriskandefficacy

B Definitionoflimitsforsettingmeta-SPCrangesC PossiblelimitationontheinclusionofdifferentformulationtypesinBPF.D Groupingofco-formulants.E DefinitionofaBPF/meta-SPCrangeforphysico-chemicalparameters.F ClarificationwhethertheassessmentofBPFsshouldbebasedontheBPF

ormeta-SPClevel.

G Establishmentofclearrulesforidentificationoftheworstcasescenario(maximumrisk/minimumefficacy).

H Applicationofparagraph77ofAnnexVItotheBPRinrelationtoBPFs.I RevisionoftheQ&Asectionandassesswhetheranypointscanbe

integratedinthegeneralguidance.

Working Partyonthe BPFconcept

• Working Partyto address issuesrelated to the BPFconcept• Initiated by the Coordination Group• Output2018(?)

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• Increasing number ofUA-APPcombined withUA-BBPand NA-BBP

• UAapplications aremainly BPFs• CombinationofUA,BPFand SBPiswinning!?

BPRapplications

Application type Nr ofapplicationsfrom Sept.2013

UA-APP 70UA-BBP(SameBiocidal Product) 45NA-APP 570NA-MRP (MutualRecognition) 2800NA-BBP(SameBiocidal Product) 950

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Major(disinfectant)ASapproved

Approval date Active Substance

2015 Iodine2016 Propan-2-ol2017 Hydrogen peroxide

CMIT/MITPeracetic acid

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Approval date Active Substance

2015 Iodine2016 Propan-2-ol2017 Hydrogen peroxide

CMIT/MITPeracetic acid

2018 AmpholytDicopper oxide (PT21)

2019 Sodium/CalciumhypochloritePropan-1-olL(+)lactic acid

2020* In-situgenerated active chlorineSodium dichloroisocyanuratePyrethrins &Pyrethroids (PT18)

Major(disinfectant)ASapproved

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• Workload (hours)2016=100

• Forecastbased onnotifications and ASapproved

• Focusondisinfectants!

Workload forecastNL

020406080

100120140160

2017 2018 2019 2020

Antifouling PT21Insecticides PT18+19Rodenticides PT14Preservatives PT6-PT13Disinfectants PT1-PT5NLTransitionalLaw

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0

20

40

60

80

100

120

2016 2017 2018 2019 2020

Pessimistic

Baseline

Optimistic

COMreportontheBPRfeemodel

• NumberofapplicationstoUA(figure4-2)

CA-May16-Doc.7.8- BPRfeemodelfinalreport.docx

Workload forecastUA (COM)

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Ctgb approachto accommodate industry demands

• SupportconceptofBiocidal ProductFamilies andformation ofconsortia

• Workload forecast• Inputfrom industry and consultants

Optimize resourcesmanagement

• Pre-submission support• Improve quality and completeness ofdossiers

Optimize workflowmanagement

Horizonscanning

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Thankyouforyourattention

marcel.hulsman@ctgb.nlservicedesk@ctgb.nl

Consultyour eCA pre-submission!