FrancophonIA/ELRC3.0 huggingface dataset:
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination Group procedure with the following amendments:
Croatian: Valjani Sažetak opisa svojstava proizvoda, označavanje i uputa o veterinarsko-medicinskom proizvodu konačne su inačice sastavljene tijekom postupka skupine za koordinaciju i sadrže sljedeće dodatke:
English: The combination of a conservative PNEC (not accounting for bioavailability) and PEC may result in an overestimate of the risk due to zinc in sediments.
Croatian: Kombinacija konzervativnog PNEC-a (ne čini bioraspoloživosti) i PEC-a može rezultirati precjenjuju rizika zbog cinka u sedimentima.
English: Therefore, exposure on application rates that are considered relevant from the use of zinc containing veterinary medicinal products are calculated from the predefined loading rates of the IDMM.
Croatian: Stoga, izlaganje stopama primjene za koje se smatra da su relevantne iz primjene veterinarsko-medicinskih proizvoda koji sadrže cink izračunato je iz prethodno definiranih stopa punjenja IDMM-a.
English: Firstly, that undiluted manure from treated piglets should be diluted before being applied to land (so that the treated manure comprises 40% or less of the total mixture).
Croatian: Prvo, da nerazrijeđeno gnojivo tretiranih praščića treba razrijediti prije nego se primjenjuje na zemlju (tako da se pomiješa tretirano gnojivo sadrži 40% ili
English: Following continual application of manure from treated animals, by 2060 an environmental risk (defined by RQ values >1) is seen in 4 of 19 soil scenarios, 5 of 15 surface water scenarios and each of the 15 sediment scenarios.
Croatian: Nakon trajne primjene gnojiva iz tretiranih životinja, do 2060. rizik za okoliš (definirani KR vrijednostima > 1) uočen je u 4 od 19 scenarija tla, 5 od 15 scenarija površinskih voda i svakom od scenarija 15 sedimenta.
English: Manure containing zinc should not be spread on the same area of land in successive years to avoid accumulation of zinc which may cause adverse effects in the environment.
Croatian: Gnojivo koje sadrži cink ne smije se rastresati na istoj površini više godina zaredom, kako bi se izbjeglo akumuliranje cinka i time spriječili negativni učinci na okoliš.
English: Supporting field studies on zinc accumulation in soils are scarce, and the available data may be considered equivocal or of limited reliability because, for example, they may not reflect the pattern of application of manure expected following the use of zinc oxide in pig breeding or soil types representative of the whole of Europe.
Croatian: Terenska ispitivanja o akumulaciji cinka u tlu koja govore u prilog su rijetka, a dostupni se podaci mogu smatrati ekvivokalnima ili ograničene pouzdanosti budući da, primjerice, ne prikazuju uzorak primjene gnojiva očekivanog nakon primjene cinkovog oksida u svinja koje se uzgajaju ili tipova tla koji su reprezentativni za cijelu Europu.
English: In terms of RMMs and in view of the necessity to prevent the accumulation of zinc in environmental compartments above PNEC levels, it has been proposed that undiluted manure from treated piglets should not be applied to land and manure from treated animals be diluted with manure from untreated animals, so that the treated manure comprises 40% or less of the total mixture.
Croatian: U smislu RMM-a i u pogledu nužnosti sprječavanja akumulacije cinka u dijelovima okoliša iznad razine PNEC-a, predloženo je da nerazrijeđen gnoj iz tretiranih prasadi ne treba primijeniti na zemlju i gnoj od liječenih životinja se razrijediti s gnojem od netretiranih životinje, tako da se tretira gnojivo sadrži 40% ili manje od ukupne smjese
English: In this procedure, the CVMP was asked to consider if the use of Gutal, a veterinary medicinal product that contains zinc oxide, a metal substance, as an active substance which is classified as very toxic to aquatic organisms, may present a potential serious risk to the environment, and if this is the case, whether risk mitigation measures can be considered relevant to adequately control and/or prevent the environmental risks.
Croatian: U ovom postupku od CVMP-a je zatraženo da razmotri predstavlja li primjena VMP-a Gutal, veterinarsko-medicinskog proizvoda koji sadrži cinkov oksid, metalnu tvar, kao djelatnu tvar koja je klasificirana kao vrlo toksična za vodene organizme, potencijalan ozbiljan rizik za okruženje, te ako je to slučaj, mogu li se mjere za smanjivanje rizika smatrati relevantnima za primjerenu kontrolu i/ili sprječavanje rizika za okruženje.
English: The Metal Bioavailability Assessment Tool is based on the outputs from the zinc Biotic Ligand Models and the dataset used in the derivation of the Environmental Quality Standard for zinc, and only requires input data for water pH, dissolved organic carbon and dissolved calcium concentration, but does not take into account the presence of other ions that could affect zinc speciation and, hence, bioavailability.
Croatian: Alat za ocjenu bioraspoloživosti metala temelji se na izlaznim podacima modela biotičkog liganda za cink i seta podataka koji se koriste u derivaciji standarda okolišne kvalitete za cink, te zahtjeva samo unos podataka za pH vode, razgrađeni organski ugljik i koncentraciju razgrađenog kalcija, no ne uzima u obzir prisutnost drugih iona koji mogu utjecati na speciaciju cinka i, stoga, bioraspoloživost.
English: However, in contrast to the CVMP/VICH approach, the IDMM predicts the fate and behaviour of zinc in soil, differentiates sites on zinc sensitivity, accommodates aged zinc, considers environmental sources of potential toxicants, and accommodates for ambient levels of naturally occurring substances.
Croatian: No, suprotno pristupu CVMP-a/VICH-a, IDMM predviđa sudbinu i ponašanje cinka u zemlji, diferencira mjesta osjetljivosti cinka, uzima u obzir stari cink, smatra okolišne izvore potencijalnih toksikanta i uzima u obzir okolišne razine tvari koje prirodno nastupaju.
English: A risk to the environment has been identified due to accumulation of zinc, particularly to the aquatic compartment.
Croatian: Rizik za okoliš je identificiran zbog nakupljanja cinka, osobito u vodenom dijelu.
English: Hence, where an excess of AVS exists and zinc sulfides are formed, the PNEC may be exceeded considerably before any adverse effects are observed.
Croatian: Stoga, u slučaju kada postoji prekomjeran AVS i dolazi do stvaranja cinkovog sulfida, PNEC se može značajno premašiti prije nego što se uoče nuspojave.
English: Quality, target animal safety, user safety impact on antimicrobial resistance development and residues were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Croatian: Kvaliteta, sigurnost ciljnih životinja, utjecaj na sigurnost korisnika na antimikrobni razvoj otpornosti i rezidua nije ispitana u ovom postupku upućivanja, a ni država članica sudionica u postupku nije iznijela nikakvu zabrinutost.
English: The bioavailability of zinc, and therefore the environmental risk, varies between soil types and environmental conditions (e.g. dissolved organic carbon, calcium and pH).
Croatian: Bioraspoloživost cinka, a stoga i opasnost za okoliš, razlikuju se prema vrstama tla i uvjetima okoliša (npr. otopljeni organski ugljik, kalcij i pH-vrijednost).
English: In the terrestrial and aquatic compartments a risk (RQ >1) was found at 4 out of 19 scenarios and at 5 of out 15 scenarios from 2060 onwards, for the worst case and lower application rate, respectively.
Croatian: Utvrđeno je da je rizik u terestrijalnim i vodenim dijelovima (R! > 1) u 4 od 19 scenarija te da je u 5 od 15 scenarija od 2060. nadalje, i to za najgori slučaj odnosno u nižoj stopi primjene.
English: Consequently, bioavailability was not considered for exposure calculations (establishing the PECs), thus leading to a risk assessment that did not account for the bioavailable fraction of zinc but rather for the total zinc concentrations (bioavailable and nonbioavailable).
Croatian: Posljedično, bioraspoloživost nije uzeta u obzir prilikom izračuna izlaganja (utvrđivanje PEC-ova), što je rezultiralo ocjenom rizika koja nije uzela u obzir dio udio raspoloživosti cinka već ukupne koncentracije cinka (bioraspoložive i nebioraspoložive).
English: Quality, target animal safety, user safety, impact on antimicrobial resistance development and residues and efficacy were not assessed in this referral procedure, as no concern was notified by the reference Member State.
Croatian: Kvaliteta, sigurnost ciljnih životinja, sigurnost korisnika, utjecaj na razvoj antimikrobne otpornosti i rezidue te djelovanje nisu ispitani u ovom postupku upućivanja, a ni država članica sudionica u postupku nije iznijela nikakvu zabrinutost.
English: In soil, properties such as pH, organic carbon content, cation exchange capacity, and clay content determine bioavailability in the terrestrial compartment.
Croatian: U zemlji, svojstva poput pH, sadržaja organskog ugljika, sposobnost izmjene kationa i udio gline utvrđuju bioraspoloživost u terestrijalnom dijelu.
English: The results of the environmental risk assessment for Gutal reflect the conclusion from EFSA on zinc i.e. there is a potential environmental concern related to the aquatic compartment (including sediment), with acidic, sandy, well-drained soils being most vulnerable to these processes.
Croatian: Rezultati ocjene rizika za okoliš za VMP Gutal prikazuju zaključke EFSA o cinku, odnosno postoji potencijalna zabrinutost za okoliš povezana s vodenim dijelom (uključujući sediment), s kiselim, pjeskovitim, dobro dreniranim tlima koja su uglavnom ranjiva za ove postupke.
English: It is acknowledged that due to the physico-chemical properties of zinc (non-volatile and nondegradable), continual application of manure from treated animals to land under practices of intensive pig breeding will cause a gradual increase in the topsoil zinc concentration, followed by an increase in other relevant compartments, over time.
Croatian: Potvrđeno je da će uslijed fizikalno-kemijskih svojstava cinka (nevolatilan i nerazgradiv), kontinuirana primjena gnojiva od tretiranih životinja na zemlji gdje je prisutna praksa intenzivnog svinjogojstva rezultirati postepenim povećanjem u koncentraciji cinka u gornjem sloju zemlje nakon čega slijedi tijekom vremena povećanje u drugim relevantnim dijelovima.
English: Toxicity will depend on environmental conditions and habitat types.
Croatian: Njegova toksičnost ovisi o uvjetima okoliša i vrstama staništa.
English: Though limited, the validation data for the IDMM is sufficient to give confidence that the model can be used to achieve an ample, pragmatic assessment of the exposure of zinc to the environment.
Croatian: Iako ograničeni, podaci o potvrdi prikupljeni IDMM-om, dostatni su kako bi potvrdili da se model može koristiti za postizanje opširne, pragmatične ocjene izlaganja cinka okolišu.
English: Zinc is very toxic to aquatic organisms and is persistent in soils and sediments.
Croatian: Cink je vrlo štetan za vodene organizme i dugo se zadržava u tlu i sedimentima.
English: Gutal 1000 g/kg premix for medicated feeding stuff for piglets (thereafter called ‘Gutal') contains zinc oxide as an active substance.
Croatian: Premiks za hranu za praščiće koja sadrži VMP Gutal 1000 g/kg (dalje u tekstu "Gutal") sadrži cinkov oksid kao djelatnu tvar.
English: The product should not be used on farms where mixing of manure from treated animals with manure of non-treated animals is not possible.
Croatian: Proizvod se ne smije koristiti na gospodarstvima na kojima odvajanje gnojiva tretiranih životinja od gnojiva netretiranih životinja nije moguće.
English: Moreover, validation of the IDMM has been performed by the comparison of model predictions against published monitoring data for zinc applications.
Croatian: Nadalje, povreda IDMM-a je izvršena usporedbom predviđanja modela i objavljenih podataka praćenja primjena cinka.
English: The proposed indication for Gutal is for the prevention of post-weaning diarrhoea in piglets.
Croatian: Predložena indikacija za Gutal glasi prevencija proljeva nakon prašenja kod praščića.
English: The product should not be used on farms where dilution of manure is not possible.
Croatian: Proizvod se ne smije koristiti na farmama gdje razrjeđivanje gnoja nije moguće.
English: Zinc is persistent in soils and may accumulate in sediments.
Croatian: Cink se dugo zadržava u tlu i može se akumulirati u sedimentima.
English: The Metal Bioavailability Assessment Tool requires fewer data inputs to predict zinc bioavailability in water than the Biotic Ligand Model, and can be used to calculate site-specific PNECs.
Croatian: Alat za ocjenu bioraspoloživosti metala zahtjeva unos manjeg broja podatak za procjenu bioraspoloživosti cinka u vodi u odnosu na model biotičkog liganda, te se može koristiti za izračunavanje PNEC-ova specifičnih za lokaciju.
English: The applicant has generated RQ values for alternative application rates via linear extrapolation of the IDMM results for application rates of 4 and 7 kg zinc ha a-1
Croatian: Podnositelj zahtjeva je generirana vrijednosti KR-a za alternativne stope aplikacija putem linearne ekstrapolacije rezultata IDMM za primjene stope od 4 i 7 kg cink ha a-1
English: Despite these uncertainties, considering the nature of the active substance, as an inorganic molecule, and the difficulties identified throughout the application procedure in terms of assessing the environmental risk for a compound ‘outside' of current CVMP/VICH guidance, it may be accepted that the estimated PEC values extrapolated from the IDMM outputs offer an reasonable reflection of the environmental exposure for use in the risk characterisation for Gutal.
Croatian: Unatoč tim nesigurnostima, s obzirom na prirodu djelatne tvari kao anorganske molekule , te teškoće identificirane tijekom postupka prijave u smislu procjene rizika za okoliš za spoj 'izvana' aktualne smjernice CVMP-a/ VICH-a, može se prihvatiti da je procijenjene vrijednosti PEC interpolacijom iz izlaznih vrijednosti IDMM-a nude razumni odraz izloženosti okoliša za uporabu u karakteriziranju rizika za Gutal.
English: Although there are uncertainties with the linear extrapolation of the IDMM results, the PEC values extrapolated from the IDMM outputs are considered to offer a reasonable reflection of the environmental exposure for use in the risk characterisation for Gutal.
Croatian: Iako postoje nejasnoće s linearnomm ekstrapolacijom rezultata IDMM-a, PEC vrijednosti ekstrapolirane iz izlaza IDMM-a smatraju ponuditi razumnu odraz izlaganja okolini za uporabu u karakterizacije rizika za Gutal.
English: Therefore, the CVMP recommended the granting of the marketing authorisations for the veterinary medicinal products referred to in Annex I with amendments to the Summary of Product Characteristics and package leaflet of the reference Member State.
Croatian: Stoga, CVMP je preporučio izdavanje odobrenja za stavljanje VMP-a u promet za veterinarskomedicinski proizvod naveden u Dodatku I. s dopunama sažetku opisa svojstava VMP-a i upute o VMP-u države članice sudionice u postupku.
English: 7 extrapolation is required, and the relationship between the zinc loading rate and the PEC values calculated by the IDMM is not linear, which could question the validity of the extrapolated PECs at the highest zinc application rates.
Croatian: 7 potrebna je ekstrapolacija, te veza izračunata između stope punjenja cinka i vrijednosti PEC-a koju je izračunao IDMM nije linearna, što čini valjanost ekstrapoliranih PEC-ova u najvećim stopama primjene cinka upitnim.
English: Effect data
Croatian: Podaci o djelovanju
English: Secondly, as the bioavailability of zinc varies between soil types, manure from treated piglets should not be spread on the soil types which have been identified as most vulnerable, i.e. freely draining, acidic (pH ≤6), sandy soils.
Croatian: Drugo, budući da bioraspoloživost cinka varira između tipova tla, gnoj od liječenih praščića ne treba širiti na vrstama tla koje su identificirane kao najranjivije , odnosno na kisela (pH ≤6), pjeskovita tla sa slobodnom drenažom.
English: Other precautions regarding impact on the environment
Croatian: Ostale mjere opreza koje se odnose na djelovanje proizvoda na okoliš
English: 4 which incorporates parameters relevant to determine soil zinc bioavailability, such as pH, organic and clay content, and the cation exchanged capacity.
Croatian: 4 u kojeg su ugrađeni parametri relevantni za utvrđivanje bioraspoloživosti cinka u zemlji, poput pH, organskog udjela i udjela gline, te sposobnost izmjene kationa.
English: Despite these uncertainties, and in the absence of a better alternative, it is considered that the IDMM can be used to gain a reasonable assessment of the risk to the environment posed by the use of Gutal.
Croatian: Usprkos ovim ne sigurnostima, te u odsutnosti bolje alternative, zaključeno je da se IDMM može koristiti kako bi se dobila razumna ocjena rizika koju predstavlja primjena VMP-a Gutal za okoliš.
English: Yet, for higher application rates than those reported using the
Croatian: Pa ipak, u slučaju većih stopa primjene od onih
English: This referral was raised due to concerns regarding the environmental risk assessment.
Croatian: Ovaj postupak upućivanja pokrenut je zbog zabrinutosti u vezi procjene rizika za okoliš.
English: Studies have shown zinc oxide to be beneficial in piglets at risk of developing mild to moderate diarrhoea.
Croatian: Ispitivanja su pokazala da cinkov oksid ima povoljno djelovanje kod praščića uz rizik razvoja blagog do umjerenog proljeva.
English: Currently, data specific to zinc are not available, however, the ability of buffer strips to reduce suspended sediment loads, which are the predominant route of transport of zinc to local water courses, may be used as an indicator.
Croatian: Trenutno nisu dostupni podaci specifični za cink nisu dostupni, međutim, kao indikator može se koristiti sposobnost tampon traka da smanje suspendirana opterećenja sedimenta, koja su dominantni put prijenosa cinka do lokalnih vodotoka.
English: 3, a user-friendly version of the Biotic Ligand Model, a model that is used to predict the bioavailable metals for different aquatic species (algae, Daphnia and fish) and has been used and well reported in a large number of peer-reviewed studies for zinc, and the data used in the EU RAR for zinc (2010).
Croatian: U vodenom dijelu, bioraspoloživost cinka u vodi procijenjena je primjenom alata za ocjenu bioraspoloživosti metala (Agencija za okoliš Ujedinjene Kraljevine) korisnički jednostavne verzije modela biotičkog liganda, modela koji se koristi za utvrđivanje bioraspoloživih metala za različite vodene vrste (alge, Dafnija i riba), te se koristio i dao je dobre izvještaje u velikom broju ispitivanja ocijenjenih od strane ravnopravnih znanstvenika za cink, a podaci su korišteni u EU RAR-u za cink (2010.).
English: The amended Summary of Product Characteristics and package leaflet of the reference Member State are set out in Annex III.
Croatian: Dopunjeni sažetak opisa svojstava VMP-a i uputa o VMP-u države članice sudionice u postupku navedeni su u Dodatki III.
English: When spreading manure from treated animals, the maximum total zinc load as defined in the national or local regulations has to be strictly respected.
Croatian: Kod rastresanja gnojiva dobivenoga od tretiranih životinja, ukupna maksimalna opterećenost cinkom utvrđena je nacionalnim i lokalnim propisima i treba se strogo poštivati.
English: • However, it is deemed appropriate that having addressed the environmental concerns of the use of Gutal and having identified an environmental risk from the use of zinc containing veterinary medicinal products, that further risk management measures are taken to reduce the accumulation of zinc in soil, water and sediment compartments.
Croatian: • No smatra se primjerenim da se zabrinutosti za okoliš zbog primjene VMP-a Gutal rjeđe te da se identificiraju rizici za okoliš koji nastaju uslijed primjene veterinarsko-medicinskih proizvoda koji sadrže cink, te da se trebaju poduzeti daljnje mjere za smanjivanje rizika kako bi se smanjilo nakupljanje cinka u tlu, vodi i sedimentu.
English: Due to the intrinsic nature of zinc (non-volatile and non-degradable) the potential for PNECs to be eventually surpassed as a result of continual application of manure from treated animals to land over an extended period is a significant environmental concern, particularly with regard to the most vulnerable soil types (acidic, freely draining, sandy soils) and organisms of the aquatic compartments.
Croatian: Zbog unutarnje prirode cinka (nevolatilan i nerazgradiv), značajnu zabrinutost za okoliš predstavlja činjenica da će se potencijal za PNEC-ove naposljetku premašiti kao rezultat kontinuirane primjene gnojiva tretiranih životinja na zemlju tijekom duljeg razdoblja, osobito s obzirom na najugroženije vrste tla (kisela, pjeskovita tla koja se slobodno dreniraju) i organizme vodenih dijelova.
English: For sediment systems, since the sediment predicted environmental concentration (PEC) was derived (EU RAR, 2010) there have been significant changes in the way sediment concentrations are determined.
Croatian: Za sustave sedimentacije, utvrđene su značajne promjene u načinu koncentracija sedimenta, budući da je izvedena predviđena okolišna koncentracija u sedimentu (PEC) (EU RAR, 2010).
English: Amendments in the relevant sections of the Summary of Product Characteristics and package leaflet
Croatian: Izmjene i dopune relevantnih odjeljaka Sažetka opisa svojstava proizvoda i uputa o veterinarsko-medicinskom proizvodu
English: Summary of Product Characteristics
Croatian: Sažetak opisa svojstava proizvoda
English: Environment Agency, United Kingdom for zinc), and were used by the applicant to establish different PNECs for each environmental compartment.
Croatian: 2 za cink), te ih je podnositelj zahtjeva koristio za utvrđivanje drugačijih PNEC-ova za svaki dio okoliša.
English: Nonetheless, although it is recognised that the proposed RMMs have deficiencies, and the extent to which they reduce the environmental risk cannot be fully quantified, they can be anticipated to slow down the accumulation of zinc in the environment.
Croatian: Ipak, iako je prepoznato da predloženi RMM-ovi imaju nedostatke, te da se ne može u potpunosti kvantificirati u kojoj mjeri smanjuju rizik za okoliš, može se očekivati da će usporiti nakupljanje cinka u okruženju.
English: ) and a lower application rate (4 kg zinc ha a-1
Croatian: ) i u nižoj stopi primjene (4 kg cinka ha a-1
English: RQs have been extrapolated (linearly) from application rates of 4 and 7 kg zinc ha a-1
Croatian: , koeficijenti rizika su ekstrapolirani (linearno) iz stopa primjene od 4 i 7 kg cinka ha a-1
English: Zinc may accumulate in soil following continual application of manure from treated animals; with acidic sandy soils being most vulnerable.
Croatian: Cink se nakon kontinuirane primjene gnojiva od tretiranih životinja može akumulirati u tlu; najosjetljivija su pjeskovita kisela tla.
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Gutal 1000 g/kg premix for medicated feeding stuff for piglets
Croatian: Znanstveni zaključci i razlozi za izdavanje odobrenja za stavljanje VMP-a u promet za premiks za hranu za praščiće koja sadrži VMP Gutal 1000 g/kg
English: Although it is recognised that the proposed RMMs have deficiencies, and the extent to which they reduce the environmental risk cannot be fully quantified, they can be anticipated to slow down the accumulation of zinc in the environment.
Croatian: Iako je prepoznato da predloženi RMM-ovi imaju nedostatke, te da se ne može u potpunosti kvantificirati u kojoj mjeri smanjuju rizik za okoliš, može se očekivati da će usporiti nakupljanje cinka u okruženju.