PKS, Beograd mr Katarina Krinulović
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1 PKS, Beograd mr Katarina Krinulović
2 Biocidni proizvodi se mogu kratko opisati kao smeše koje sadrže jednu ili više aktivnih supstanci, a koje su namenjene za suzbijanje nepoželjnih organizama na najrazličitijim površinama i u najrazličitijim oblastima (ali ne u poljoprivrednim zonama).
3 Biocidni proizvodi razvrstavaju se u 23 vrste (PT) prema: načinu korišćenja, organizmu na koji deluju, prostoru u kojem se koriste i površini koja se tretira 4 osnovne grupe BP: 1. Dezinficijensi 2. Konzervansi 3. BP za suzbijanje štetočina 4. Ostale vrste BP
4 Grupa 1 : Dezinficijensi i biocidni proizvodi za opštu upotrebu PT 1: Biocidni proizvodi za ličnu higijenu ljudi -za održavanje lične higijene ljudi. PT 2: Dezinficijensi i drugi biocidni proizvodi koji se koriste u domaćinstvu i u objektima javnog zdravlja PT 3: Biocidni prozvodi za higijenu u veterini PT 4: Dezinficijensi koji se koriste za površine koje dolaze u kontakt sa hranom za ljude i životinje PT 5: Dezinficijensi za vodu za piće -u domaćinstvima, javnim i industrijskim objektima, uključujući i bolnice, za dezinfekciju vazduha, površina, materijala, opreme i nameštaja koji nisu u direktnom kontaktu sa hranom za ljude ili životinje. -u bazenima, akvarijumima, vodi za kupanje i druge svrhe (ukljućujući algacide); u klima uređajima; za zidove i podove u zdravstvenim i drugim ustanovama; ili druge podloge (na igralištima). -za održavanje higijene u veterini, uključujući proizvode koji se koriste u prostorima u kojima se životinje drže, čuvaju ili transportuju. -za dezinfekciju opreme, ambalaže, pribora za jelo, površina ili cevovoda koji dolaze u kontakt sa hranom ili pićem (uključujući vodu za piće) u toku proizvodnje, transporta, skladištenja ili potrošnje. -za dezinfekciju vode za piće za ljude i životinje.
5 PT 6: Konzervansi za zaštitu gotovih proizvoda PT 7: Konzervansi za zaštitu filmova PT 8: Konzervansi za zaštitu drveta PT 9: Konzervansi za zaštitu vlakna, kože, gume i polimernih materijala Grupa 2 : Konzervansi Ova vrsta biocidnih proizvoda koristi se za zaštitu gotovih proizvoda (osim hrane za ljude i životinje) dok su u originalnoj ambalaži, od štetnog delovanja mikroorganizama, kako bi se očuvao kvalitet proizvoda do naznačenog roka upotrebe. Ova vrsta biocidnih proizvoda koristi se za zaštitu filmova ili premaza od štetnog delovanja mikroorganizama, kako bi se očuvale početne osobine površine materijala ili predmeta kao što su boje, plastika, zaptivna sredstva, zidne tapete, papir i umetnička dela. Ova vrsta biocidnih proizvoda koristi se za zaštitu drveta, uključujući i samu obradu drveta u strugari, ili proizvoda od drveta, od organizama koji uništavaju ili oštećuju drvo. Ova vrsta biocidnih proizvoda koristi se za zaštitu vlaknastih ili polimernih materijala, kao što su proizvodi od kože, gume, papira ili tekstila, kao i same gume od štetnog delovanja mikroorganizama. PT 10: Konzervansi za zaštitu u građevinarstvu PT 11: Konzervansi za zaštitu tečnosti u rashladnim i procesnim sistemima PT 12: Slimicidi PT 13: Konzervansi za zaštitu fluida koji se koriste pri obradi metala Ova vrsta biocidnih proizvoda koristi se za zaštitu i naknadni tretman građevinskih ili drugih konstrukcionih materijala, izuzev drveta, od štetnog delovanja mikroorganizama i algi. Ova vrsta biocidnih proizvoda koristi se za zaštitu vode ili drugih tečnosti koje se koriste u rashladnim i procesnim sistemima, od štetnog delovanja organizama kao što su mikroorganizmi, alge i školjke Ova vrsta biocidnih proizvoda koristi se za sprečavanje ili suzbijanje razvoja sluzi na materijalima, opremi i predmetima koji se koriste u industrijskim procesima, npr. na drvenoj ili papirnoj pulpi. Ova vrsta biocidnih proizvoda koristi se za zaštitu fluida koji se koriste pri obradi metala od štetnog delovanja mikroorganizama
6 Grupa 3 : Biocidni proizvodi za suzbijanje štetočina za suzbijanje miševa, pacova i drugih glodara. PT 14: Rodenticidi PT 15: Avicidi PT 16: Moluskocidi PT 17: Piscicidi PT 18: Insekticidi, akaricidi i proizvodi za suzbijanje ostalih zglavkara PT 19: Repelenti i atraktanti za suzbijanje ptica. za suzbijanje mekušaca za suzbijanje riba. U ovu vrstu biocidnih proizvoda ne spadaju proizvodi koji se koriste za lečenje bolesti riba. za suzbijanje zglavkara (npr. insekata, paukova, rakova). za suzbijanje štetnih organizama (beskičmenjaka kao što su buve i kičmenjaka kao što su ptice) odbijanjem ili privlačenjem. U ovu vrstu biocidnih proizvoda spadaju proizvodi koji se direktno ili indirektno koriste za ličnu higijenu ljudi ili za higijenu u veterini.
7 Grupa 4 : Ostale vrste biocidnih proizvoda PT 20: Konzervansi za hranu ili hranu za životinje PT 21: Sredstva za suzbijanje obrastanja (eng. antifauling) PT 22: Tečnosti za balsamovanje i prepariranje PT 23: Proizvodi za suzbijanje drugih kičmenjaka za zaštitu hrane ili hrane za životinje od štetnih organizama. za suzbijanje razvoja i nastanjivanja nepoželjnih organizama (mikroorganizama i složenijih biljnih ili životinjskih vrsta) na čamcima, opremi i predmetima koji se koriste u vodi. za dezinfekciju i zaštitu ljudskih ili životinjskih leševa i njihovih delova. za suzbijanje drugih štetočina koje se ne mogu suzbiti drugim vrstama biocidnih proizvoda
8 Zbog rizika koji su povezani sa upotrebom BP, njihovo stavljanje u promet i korišćenje je pod posebnim regulatornim režimom i u Srbiji i u EU sa ciljem da se obezbedi da se promet stavljaju samo biocidni proizvodi koji su dovoljno efikasni da unište nepoželjne organizme, a takvi da ne predstavljaju neprihvatljiv rizik po zdravlje i životnu sredinu.
9 Nova EU Uredba o biocidnim proizvodima - BPR usvojena je 22. maja 2012, a primenjuje se od 1.sept U pravno-formalnom smislu zamenjuje ranije vazeću direktivu BPD, ali sustinski zasniva se na istim principima i regulatornom konceptu, s tim da uvodi određena poboljšanja i novi centralni nadležni organ ECHA, što će dovesti do boljeg funkcionisanja sistema upravljanja BP u EU.
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11 U Srbiji, do na biocidne prozvode, odnosno na pojedine PT se primenjivalo nekoliko različitih zakona. Donošenjem Zakona o biocidnim proizvodima uveden je jedinstven regulatorni sistem za sve vrste biocidnih proizvoda po modelu iz EU. Harmonizacija
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13 Osnovni USLOV: 1. dostavljene Osnovne informacije o BP i AS i 2. Aktivna supstanca upisana u: Liste odobrenih aktivnih supstanci (Lista I/Ia) ili Program (Review Programme) i to za odgovarajuću vrstu (PT) i ne sme da postoji upis AS u Listu II (non-inclusion decision) za tu vrstu (PT) Odobrenje za stavljanje BP u promet Osnovni USLOV: 1. dostavljen Tehnički dosije radi procene rizika 2. Aktivna supstanca upisana u: Liste odobrenih aktivnih supstanci (Lista I/Ia) i to za odgovarajuću vrstu (PT)
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15 IDENTIFIKACIJA AS NOTIFIKACIJA AS ROK Da li je Tehnički dosije dostavljen? ДА EVALUACIJA AS NE Program uključivanja aktivne supstance AS u Liste aktivnih supstanci EU (EU Review programme ) ODLUKA O NEUKLJUČIVANJU U LISTE AS Da li AS predstavlja prihvatljiv rizik? DA ODLUKA O UKLJUČIVANJU U LISTE AS NE
16 EU Review programme bitni dokumenti Commission Regulation (EC) No 1451/2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC (Annex 2. List of AS vs. PTs included) Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012
17 Prioritetne liste PT radi uključivanja AS u Liste aktivnih supstanci EU (EU Review programme - Regulation (EC) No 1451/2007 ) STEPEN PRIORITETA Vrsta biocidnog proizvoda Tehnički dosije Odluka o uključivanju u liste AS PT 8 PT 14 PT16 PT18 PT19 PT21 Odluka do 2024 Do Do Do Do PT 1 PT 2 PT 3 PT 4 PT 5 PT 6 PT 13 Do Do PT 7 PT 9 PT 10 PT 11 PT 12 PT 15 PT 17 PT 20 PT 22 PT 23 Do Do
18 Nove Prioritetne liste PT radi uključivanja AS u Liste aktivnih supstanci EU nakon donošenja BPR i pratećih odluka (CA-Sept13-Doc.8.3 Final) Priority Existing active substances for product types All draft CARs have to be submitted to ECHA by The BPC have to submit all its opinions by 1 st priority list 8, 14, 16, 18, 19, 21 31/12/ /12/ nd priority list 3, 4, 5 31/12/ /12/ rd priority list 1, 2 31/12/ /12/ th priority list 6, 13 31/12/ /12/ th priority list 7, 9, 10 31/12/ /12/ th priority list 11, 12,15,17, 22, 23 (new PT20 under BPR) 31/12/ /06/2024
19 Biocidal Products Committee - BPC - Od primene BPR sept mišljenja o AS donosi ECHA BPC - BPC misljenja su dostupna na - U proteklih godinu dana doneseno 34 mišljenja BPC - Postupak evaluacije AS je ubrzan npr. početkom doneto 13 mišljenja (1 je negativno ua Triflurmuron - PT 18) - Na osnovu ovih mišljenja EC donosi odluku o uključivanju u liste AS
20 Lista odobrenih aktivnih supstanci u EU Lista se preuzima u Listu I/Ia Listi aktivnih supstanci ("Sl. glasnik RS", br. 72/2014)
21 Lista zabranjenih aktivnih supstanci u EU es/active-substances/non_inclusion_en.htm Lista se preuzima u Listu II Listi aktivnih supstanci u biocidnom proizvodu ("Sl. glasnik RS", br. 72/2014)
22 Status AS vs. mogućnosti za plasman BP na srpsko tržište Primeri: Aluminijum fosfid koji ispušta fosfin (CAS ) nije dozvoljen za PT 8 (Lista II), ali je dozvoljen za PT 14 i PT18 (Lista I), dakle biocidni proizvod koji sadrzi ovu AS može se registrovati tj. upisati u Privremenu listu i stavljati u promet kao rodenticid ili insekticid, ali ne kao sredstvo protiv žiška u drvetu. Etanol, n-propanol i izo-propanol su još uvek uvek u postupku evaluacije AS u okviru Review programe za PT 1, PT2, i PT4 i stoga su dozvoljeni u ovakvim dezinficijensima ali nisu dozvoljeni u PT3 i PT5
23 Predstojeće obaveze snabdevača BP u EU Počev od 1. Sept. 2015, BP koji sadrži konkretnu AS ne može biti na tržištu EU ukoliko snabdevač AS i/ili BP nije naveden na Listi snabdevača AS u vezi člana 95. BPR za odgovarajući PT. Da bi snabdevač izvršio ovu obavezu on mora dostaviti ECHA dosije za AS ili tzv. Pismo pristupa podacima (LoA). ECHA redovno ažurira ovu listu - U kontekstu liste iz Člana 95 BPR koji se suštinski odnosi na tranzicione mere u pogledu pristupa dosijeu za AS, a radi izbegavanja ponavljanja testova na životinjama, uvedena je obavezujuća razmena podataka (uz adekvatnu deobu troškova testiranja). Ovaj uslov još uvek ne postoji za plasiranje BP na srpsko tržište, ali ovo će biti primarni zahtev u trenutku kada članstvo Srbije EU postane izvesno. Ovo treba imati na umu prilikom odabira inopartnera za nabavku BP ili AS.
24 Status AS u vezi sa uključivanjem u Liste AS BP mora sadržati AS čije je korišćenje dozvoljeno za odgovarajuću vrstu biocidnog proizvoda (PT) Ovaj uslov važi i u EU i u Srbiji Status snabdevača AS u vezi sa uključivanjem u Liste snabdevača iz čl. 95. BPR U EU nakon 1.septembra neće biti moguće stavljanje u promet BP koji sadrže AS čiji snabdevači nisu navedeni na listi snabdevača iz čl. 95. BPR ovaj uslov još uvek nije definisan u srpskoj legislativi o BP
25 Šta predstoji u pogledu srpske legislative o BP? Manje izmene ZoBP (predlog već upućen Skupštini na usvajanje) radi predefinisanja nadležnog organa i podele nadležnosti inspekcija, ali i davanja pravnog osnova za uređivanje taksi Izmenama ZoBP predviđeno je da se novi podzakonski propis o taksama donese u roku od 3 meseca Češće ažuriranje Liste AS kao posledicu očekivanog ubrzanja evaluacije AS u EU Usaglašavanje nacionalne legislative sa BPR po NPI u 2016.
26 Šta se očekuje u pogledu registracionih postupaka/dokumentacije/akata? Nastavak stavljanja u promet na osnovu rešenja iz tranzicionog postupka (upis BP u PL), osim ukoliko se u EU donese odluka o odbijanju upisa AS u Liste odobrenih AS Produženje rokova za dostavljanje tehničkog dosijea, dok se ne stvore kapaciteti/mehanizmi za sprovođenje procedure autorizacije tj. izdavanje odobrenja Intenzivni zahtevi za podacima/loa/dokumentacijom pred ulazak Srbije u EU
27 HVALA NA PAŽNJI! Katarina Krinulović mob
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