Product authorisation in case of in situ generation
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- Maude Cummings
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1 Prduct authrisatin in case f in situ generatin Intrductin At the 74 th CA meeting (27-29 September 2017), Aqua Eurpa and ECA Cnsrtium presented their cncerns and prpsals n the management f the prduct authrisatin stage fr 'in situ generatin' cases (CA-Sept17-Dc.4.8-a and CA-Sept17-Dc.4.8-b). They indicated the diversity f in situ systems/devices n the market and prpsed a generic apprach, identifying the wrst case(s) scenari(s) t be evaluated in the risk assessment. By Octber 20 th, 2017, three cmments were received n this prpsal: - Aqua Eurpa & ECA: thughts and ideas n ptential next steps: Implement a wrking grup with representatives frm interested CAs and industry stakehlders fr the develpment f a guidance dcument. Input frm industry: expert knwledge and practical experience; Supprt ffered t eventual questins frm CAs fr cmmenting n psitin paper; Suggested milestnes and respnsibilities: t determine key parameters fr the definitin f an utput and perfrmance envelpe ; t further assess and cnsider existing regulatins and technical standards against the backgrund f the requirements fr bicidal prduct authrisatin; t develp a draft guidance beginning f Ctgb (CA, the Netherlands): An imprtant questin is whether reference can be made t the device in the SPC and hw t d that; Fr cmplex in situ systems (ISS) using generally available precursrs r precursrs that cannt be authrised: Need fr cnnectin f the device that is used fr generatin in sme way t the authrisatin. Or: the bicidal prduct must be labelled and the nly way t d that is by putting the label n the device; Fr inspectin after authrisatin, it is necessary that it can be recgnised that a prduct is authrised and that the in situ prduct that is used in practice is the same as the prduct that is authrised (Output range f reactin is specified in the SPC); Nt up t the CA s t decide n the standardisatin that Aqua Eurpa is asking fr; Up t industry t shw whether it is pssible t grup ISS using existing standards; Imprtant that the active substances, impurities and disinfectin by-prducts that cnstitute the utput f the system can be assessed fr authrisatin; 1
2 A specific variatin in utput is acceptable as lng as it is pssible that the utput envelp can be defined clearly; The technical and ther measures that can be taken t ensure that the utput f all devices will fall within a perfrmance envelp, which has t be develped by industries themselves. - KEMI (CA, Sweden): Supprts the general principle that it shuld be pssible t use a generic apprach fr authrisatin f in situ generatin systems; Start t discuss hw in situ generated bicides will be authrised; As NL als mentins, an imprtant questin is whether reference can r shuld be made t the device in the SPC and if s, hw t d that; Cncern: Hw shuld ISS devices already placed n the market and in use, be regulated and authrised, especially when the cmpany respnsible fr the placing n the market des nt exist anymre? At the 75 th CA meeting (23-24 Nvember 2017) there was very limited discussin f the authrisatin prcedures f device-based ISS. The three cmments received by 20 th Octber 2017 were nted. Prpsal f EurO3zn fr prduct authrisatin in case f in situ generatin EurO 3zn ivzw is an Internatinal Nn-Prfit Assciatin dedicated t prmting the use f Ozne (O 3) in Eurpe. The member cmpanies c-perate in matters cncerning zne applicatins that are regulated by the Eurpean Bicidal Prducts Regulatin (BPR, Regulatin (EU) N 528/2012). This is including zne manufacturers, gas suppliers and ther assciatins. Members f EurO 3zn are als initiating and supprting the develpment f technical standards in the field f zne treatment. Additinally they are prviding technlgical expertise t standardizatin bdies and related assciatins. EurO 3zn wuld like t add their visin t the abve discussin, frm the viewpint f zne as an in situ generated active substance / bicidal prduct. General psitin and prpsal by EurO3zn: The requirements fr a safe and reliable peratin f in situ system (ISS) devices are described already in widely acknwledged and applied Eurpean and natinal guidelines and standards. Abve all fr device-based ISS is imprtant what cmes ut f these devices: Technical active substance generated in situ N bligatin and n legal base exist t authrise devices (Article 17 BPR) 2
3 Hwever, preferentially device manufacturers f ISS cmmit themselves t cmplete prduct authrisatin and t becme the authrisatin hlders. A cnnectin between the devices (r a series f devices) and the authrisatin dssier shuld hwever be made. As indicated by the Ctgb, this culd be in the SPC. EurO 3zn wuld suggest t list at level 3 f the SPC f the BP family (see further BP family SPC: three level apprach ) all in situ devices by their generic brand and/r manufacturer names (n prduct-series names and mdel numbers), characterised by their utput 1, and fitting t the utput ranges defined in level 2 (meta-spc). It shuld be able t add future devices that fall within the bundary envelpe as an administrative change 2. In case precursrs are nt subject f authrisatin a prduct label is t be placed n the ISS device 3 in rder t illustrate the authrizatin f the BP generated by that ISS device. Besides utput characterisatin and a shrt descriptin f the in situ generatin methd, n ther technical specificatin f the equipment is needed in the BP dssier. Supprt fr the generic apprach as prpsed by Aqua Eurpa and ECA (CA-Sept17-Dc.4.8-a and CA- Sept17-Dc.4.8-b): Identify wrst case cnditins cnsidering existing regulatins and standards fr the precursr surces, devices and use scenaris f applicatin and use. Cluster in situ devices by implementing an integrated, generic apprach, in terms f expsure scenaris fr human health and envirnment. Demnstrate fr a grup f device-based ISS, using different precursr surces/qualities, (different water qualities) and different devices, that the in situ generated active substance quality is within the pre-defined specificatins. T deliver and/r prduce relevant data in accrdance with the BPR prvisins fr this integrated, generic apprach. Older systems/devices installed befre apprval: If manufacturer still exists: The manufacturer nly n request f the wner and/r peratr f these lder devices and if there is n need t replace yet said device, makes sure the device falls within the bundary envelpe defined in prduct authrisatin and prvides any necessary labels. If rphan device (manufacturer respnsible fr bringing the device n the market des nt exist anymre): the respnsibility fr regulatry cmpliance f bicidal prduct generated by such rphan devices belngs t the end-user, the natinal authrities r any third party that is willing t take up respnsibility. It is hwever, in general, unlikely that the individual end-user will manage this by himself. 1 instead f having individual bicidal prducts, which cannt be defined fr ISS generated bicidal prducts 2 E.g. in case a new prtfli f generatrs (new brand names) is develped 3 This als applies if the use f authrized precursrs is nt sufficient t ensure that the utput f the device cmplies with the SPC 3
4 Specific prpsal f EurO3zn fr devices fr generating zne in situ: EurO 3zn wants t ensure the cntinuatin f zne-based disinfectin at feasible / reasnable effrt fr authrities and zne device manufacturers. Precursrs fr zne: n precursrs with bicidal claim exist n the market, nly: available generic precursrs (liquid xygen) precursrs that cannt be authrised (air, xygen made in situ frm air, water) Therefre, the bicidal prduct t be authrised is (equal t) the technical active substance zne generated in situ. As far as the active substance and the bicidal prduct are t be cnsidered equivalent, there are ultimately n further authrisatin requirements deemed necessary as a safe use has already been prven as part f the active substance apprval. The zne in situ devices are designed such that, depending n varius peratinal factrs (such as precursr identity, quality/cmpsitin) and settings (specific energy, ), the devices themselves are able t prduce a wide range f technical zne cncentratins within a bundary envelpe. There is a wide variety f zne devices, each able t prduce a variety f technical in situ zne a situatin that is cmparable with ISS devices generating ther active substances. Therefre, it is impssible t define individual zne prducts that are characterised by a fixed percentage f zne cntent and link them t a device. It is the utput f the zne ISS what receives authrisatin as BP and in the SPC the fllwing is defined (1) a bundary utput envelpe f zne, and (2) zne use cncentratin ranges fr the individual uses, fr zne typically based n efficacy results btained in simulated use r field testing. (1) and (2) are taken ver in the authrisatin act and the prduct label. This prduct label is placed n the device. Definitin f Ozne utput vs Ozne use cncentratin : Ozne utput : expresses the pure zne cntent in the technical zne generated in situ (zne in gas r zne in water), at the time f generatin (% w/w). Mre specific, zne utput can mean: a) Ozne cncentratin (in gas-phase / air r xygen as wt% r g/nm³ gas) b) Ozne capacity = g r kg zne generated per hur Ozne use cncentratin is the applied zne in the media (water r air) expressed in g zne/m³ water r air. This is nt the actual measured r finally fund, residual r disslved zne cncentratin. Ozne use cncentratin is actually a better characterisatin f the prduct in use, since fr efficacy and risk assessment the actually applied zne is f prime imprtance. The aspect f use cncentratin ( use case in Aqua Eurpa/ECA dc) frms indeed an imprtant aspect in the wrst case expsure scenaris. In Germany there is an existing nrm, DIN ("Oznerzeugungsanlagen zur Wasseraufbereitung"), defining safe peratin scenaris fr zne. The nrm is planned t be upgraded t an EN standard. 4
5 BP family SPC: three level apprach Level 1: BP Family Level 2: Meta-SPCs Level 3: individual prducts n level 2, the generic apprach can result in definitin f clusters f device utput ranges (cntent f active substance, cntent f nn-active substances), taking int accunt authrised uses and crrespnding wrst case scenaris fr risk assessment. Ideally, such a cluster is then defined in a meta- SPC. Several clusters / meta-spcs will make up the family (level 1). n level 3, instead f individual prducts, which cannt be defined fr ISS based bicidal prducts, it wuld be an ptin t list all ISS devices, characterised by their utput, and fitting t the utput ranges defined in level 2. 5
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