Embed Size (px)
Citation preview
ExperienceswithBPF(andUA)aseCA
MarcelHulsmanCtgb AccountManagerBiocides
BPRSymposiumARCHE- pIEtBrussels,17October2017
2
Firstexperiences onBPFand UA
UAand BPF:newconcepts• Firstevaluations finalised• Firstexperience onpeerreviewphase
MostUAapplicationsareBiocidalProductFamilies• EvaluationphasebasicallysimilartoNA• ComplexitydeterminedbyBPFstructure
Takehomemessages• BeawareofongoingdiscussionsonBPF• SMEconsiderjoiningaconsortium
and/orapplyviaSameBiocidalProduct• ConsultyoureCA pre-submission
3
Outline
• UApre-submission,guidance and support
• UAprogress
• Outlookontheforthcoming approval of
(disinfection)active substances
4
UnionAuthorisation
• AuthorisationgrantedbytheEuropeanCommission,validontheentireEUmarket
• Forsinglebiocidalproductsandproductfamilies
• Excluded:
o Productscontainingsubstancesfulfillingtheexclusioncriteria(Article5ofBPR)
o Productstocontrolrodents,birds,fish,andothervertebrates(PTs14,15,17and20)
o Antifoulingproducts(PT21)
5
• 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
6
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)
7
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)
8
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
9
eCAeCA
Dossierevaluation(365days)
PARanddraftSPCtotheapplicant
Possibilityforwritten
comments(30days)
APPLICANT
RevisionofPARanddraftSPC
eCA
Ifadditionalinformationrequired,suspensionoftheevaluationperiodnotexceeding180daysintotal
Peerreviewstarts
ECHA
UAEvaluation
10
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
11
FirstUAapplicationsenteredthepeerreviewphase:BPFbasedoniodine/PVPiodine(PT3-PT4)
2applicationsforeseenfordiscussionat:• WG-IV-2017(September2017)• BPC-23(December2017)
• 2UA-BBPslinked
UAProgress
12
Firstexperiences (1)
NationalAuthorisationand MutualRecognition• Bilateral discussions• Fewformal disagreements (Coordination Group)
13
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
14
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
15
Firstexperiences (2)
NationalAuthorisationand MutualRecognition• Bilateral discussions• Fewformal disagreements (Coordination Group)
UnionAuthorisation:newconcept• Firstevaluations finalised• Firstexperience onpeerreviewphase
MostUAapplicationsareBiocidalProductFamilies• EvaluationphasebasicallysimilartoNA• ComplexitydeterminedbyBPFstructure
16
• 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
17
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
18
Ctgb Prioritylistvalidation (1)
https://english.ctgb.nl/biocidal-products/application-process/intake-phase
19
Ctgb Prioritylistvalidation (2)
https://english.ctgb.nl/biocidal-products/application-process/intake-phase
20
Ctgb Prioritylistvalidation (3)
https://english.ctgb.nl/biocidal-products/application-process/intake-phase
21
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
22
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(?)
23
• 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
24
Major(disinfectant)ASapproved
Approval date Active Substance
2015 Iodine2016 Propan-2-ol2017 Hydrogen peroxide
CMIT/MITPeracetic acid
25
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
26
• 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
27
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)
28
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
