FrancophonIA/ELRC3.0 huggingface dataset:
English: , except in instances where they may not be line with common agricultural practice in a particular Member State, for example, in Member States where manure trading is common and, hence, the farmer may not be the person spreading the manure, or in instances where the effect of the RMM has not been definitively demonstrated (e.g. buffer zones).
Croatian: , osim u slučajevima u kojima oni ne mogu biti u skladu sa zajedničkom poljoprivrednom praksom u pojedinoj državi članici, na primjer, u državama članicama u kojima je trgovanje gnojivom uobičajeno i, stoga, poljoprivrednik ne može biti osoba koja širi gnojivo, ili u slučajevima gdje učinak RMM nije definitivno utvrđen (npr. tampon zone).
English: Zinc oxide is included in veterinary medicinal products currently authorised in several EU Member States for use in pigs.
Croatian: Cinkov oksid je uključen u veterinarsko-medicinske proizvode koji su trenutno odobreni u nekoliko država članica EU.
English: Having considered the above, it can be accepted that the PNECs proposed by the applicant can be used for the characterisation of risks (calculation of risk quotients).
Croatian: Uzimajući u obzir prethodno navedeno, prihvaćeno je da se PNEC-ovi predloženi od strane podnositelja zahtjeva mogu koristiti za karakterizaciju rizika (izračun kvocijenta rizika).
English: Consequently an ‘ageing' factor of 3 has been established and is used in calculating site-specific PNECs.
Croatian: Posljedično, utvrđen je čimbenik "starenja" 3 i koristi se za izračun PNECova specifičnih za lokaciju.
English: The final RMM proposed is to apply local or national rules for the minimum distance from open water at which manure should be spread.
Croatian: Konačni predloženi RMM jest da se primjene lokalna ili nacionalna pravila za minimalne udaljenosti od otvorene vode na kojima se gnojivo treba širiti.
English: However, it is noted that the level of uncertainty in the risk characterisation for sediment is considerably greater than for soil or surface water.
Croatian: Međutim, on je istaknuo da je razina neizvjesnosti u karakteriziranju rizika za sediment bila znatno više nego za tlo ili površinske vode.
English: Do not contaminate surface waters or ditches with the product or used containers.
Croatian: Podzemne vode ili jarke nemojte zagađivati proizvodom ili iskorištenim spremnicima.
English: This supportive data suggests a buffer zone of 3 m or more could reduce the run-off by 3 to 5-fold.
Croatian: Ovi podaci, koji to potvrđuju, ukazuju da bi tampon zona od 3 m ili više mogla smanjiti istjecanje 3-5 puta.
English: In major pig breeding regions stringent rules and controls on manure application are in place, although it is realised that this advice is followed on a voluntary basis and Good Agricultural Practice may vary throughout the Member States.
Croatian: U glavnim svinjogojstvenim područjima stroga pravila i kontrole na gnoja prijave su na snazi, iako je shvatio da je ovaj savjet je slijedio na dobrovoljnoj osnovi i dobre poljoprivredne prakse može varirati od države članice do države članice.
English: A pragmatic approach should be taken when considering the validation of environmental mechanistic models (e.g. IDMM and FOCUS
Croatian: Potrebno je odabrati pragmatičan pristup prilikom razmatranja potvrde mehaničkih modela za okoliš (primjerice IDMM i FOCUS
English: Since the issues raised by France and the Netherlands remained unresolved, the Member States concerned failed to reach an agreement regarding the product and consequently the matter was referred to the CVMP on 30 September 2014 under Article 33(4) of Directive 2001/82/EC.
Croatian: Budući da pitanja, koja su istaknule Francuska i Nizozemska, ostaju neriješena, države članice sudionice u postupku nisu mogle postići sporazum vezano uz proizvod, te je posljedično predmet upućen CVMP-u dana 30. rujna 2014. u skladu sa člankom 33. stavkom 4.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, route of administration, applicant in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačine veterinarskomedicinskih proizvoda, vrsta životinja i načina izdavanja koji se primjenjuju u državama članicama
English: At present it is uncertain as to what represents a reasonable worst case exposure scenario for the manure application rate.
Croatian: Trenutno je nejasno što bi predstavljalo razuman najgori scenarij izloženosti predmeta za stopu primjene gnojiva.
English: Additionally, advice to avoid the spreading of manure on the same area of land in successive years in order to slow down the accumulation of zinc would seem a suitable RMM.
Croatian: Osim toga, savjet kako bi se izbjeglo širenje gnojiva na istom području zemlje u uzastopnim godinama sa ciljem usporavanja nakupljanja cinka čini se prikladan RMM-om.
English: Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Croatian: Svaki neiskorišteni veterinarsko-medicinski proizvod ili otpadni materijal nastao korištenjem takvog veterinarsko-medicinskog proizvoda treba zbrinuti u skladu s lokalnih propisima.
English: Usually piglets and sows are kept on the same farm allowing treated piglet manure to be diluted.
Croatian: Obično se praščići i nazimice drže na istoj farmi što omogućuje razrijeđivanje gnojiva liječenih praščića.
English: For each compartment (soil, water and sediment), zinc bioavailability is dependent on various biotic and abiotic factors.
Croatian: Za svaki dio (zemlja, voda i sediment), bioraspoloživost cinka ovisi o različitim biotičkim i abiotičkim čimbenicima.
English: During the CMD(v) procedure Belgium concluded that a marketing authorisation for Gutal can be granted provided that RMMs are included in the product information.
Croatian: Tijekom postupka CMD(v)-a, Belgija je zaključila da se odobrenje za stavljanje u promet VMP-a za Gutal može odobriti ukoliko se RMM-ovi uključe u informacije o proizvodu.
English: The predicted no effect concentrations (PNECs) reported in the European Union Risk Assessment Report (EU RAR) on zinc (2010)
Croatian: Predviđene koncentracije bez djelovanja (PNEC-ovi) prijavljeni u Izvješću za ocjenu rizika Europske unije (EU RAR) za cink (2010.)
English: In order to reduce the risk from the accumulation of zinc in environmental compartments, a number of RMMs are proposed to be included in the product information.
Croatian: Kako bi se smanjio rizik od nakupljanja cinka u dijelovima okoliša, predloženo je nekoliko RMM-ova koji bi se trebali uključiti u informacije o proizvodu.
English: The information provided indicates that there are errors and these are more pronounced for the sediment compartment and at low loadings.
Croatian: Dostavljene informacije ukazuju da postoje pogreške, te da su iste izraženije za dio sedimenta i u manjim punjenjima.
English: The applicant provided the robust summaries of the additional peer-reviewed studies used in the effect assessment that were not included in the EU RAR (2010), including a conclusion on the reliability and validity of each study.
Croatian: Podnositelj zahtjeva dostavio je grube sažetke dodatnih ispitivanja pregledanih od strane ravnopravne skupine znanstvenika korištenih u ocjeni djelovanja, a koja nisu bila uključena u EU RAR (2010.), uključujući i zaključak o pouzdanosti i valjanosti svakog ispitivanja.
English: As zinc is a metal, general assumptions that are usually made about degradation are not applicable, therefore, once critical concentrations are exceeded, the risk will be difficult to remediate.
Croatian: Kao što je cink metal, opće pretpostavke koje su obično donijete o degradaciji nisu primjenjive, dakle, nakon što su kritične koncentracije premašene, rizik će biti teško sanirati.
English: The CVMP was asked to give its opinion on the concerns raised by France and the Netherlands and to conclude on the benefit-risk balance for Gutal.
Croatian: Od CVMP-a je zatraženo da iznese svoje mišljenje o pitanjima koja su postavile Francuska i Nizozemska, te da donese zaključak o omjeru koristi i rizika za VMP Gutal.
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Croatian: 6.6 Posebne mjere opreza kod zbrinjavanja neiskorištenih veterinarsko-medicinskih proizvoda ili otpadnih materijala nastalih korištenjem takvih proizvoda
English: Thus, a model used by EFSA for estimating the environmental exposure from the use of zinc oxide as feed additive, the Intermediate Dynamic Model for Metal (IDMM) by Monteiro et al. (2010)
Croatian: Stoga, model kojeg je koristila EFSA za procjenu okolišnog izlaganja iz primjene cinkovog oksida kao aditiv za hranu, srednji dinamički model za metal (IDMM) od strane Monteiro et al. (2010.)
English: Zinc is very toxic to aquatic organisms, but can affect growth, survival and reproduction in both aquatic and terrestrial plants and animals.
Croatian: Cink je vrlo toksičan za vodene organizme i utječe na rast, preživljavanje i razmnožavanje kako vodenih tako i kopnenih biljaka i životinja.
English: Although limited data were available, results show zinc concentrations are predicted accurately in soils but less so in surface waters and sediment.
Croatian: Iako su dostupni ograničeni podaci, rezultati pokazuju da su koncentracije cinka točno predviđene u tlu, no to nije slučaj u površnim vodama i sedimentu.
English: The calculation of site-specific PNECs for Gutal was carried out using an Excel tool soil PNEC calculator (developed by Arche Consulting)
Croatian: Izračun PNEC-ova specifičnih za lokaciju za VMP Gutal proveden je primjenom računara Excel alata za PNEC tla (koji je razvijen od strane tvrtke Arche Consulting)
English: A critical consideration in relation to assessing environmental risk of metals is determining their bioavailability.
Croatian: Kritičnim razmatranjem povezanim s ocjenom rizika za okoliš metala utvrđena je njihova bioraspoloživost.
English: 1 are considered reliable and, hence, are suitable for use in the risk characterisation of Gutal.
Croatian: 1 smatraju se pouzdanima te, stoga, su pogodne za primjenu pri karakterizaciji rizika lijeka Gutal.
English: The proposed RMMs fulfil the criteria laid out in the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6
Croatian: Predloženi RMM-ovi ispunjavaju kriterije utvrđene u smjernici CVMP-a o procjeni utjecaja na okoliš za veterinarsko-medicinske proizvode u potporu smjernicama VICH-a GL6
English: Metal bioavailability assessment tool (M-BAT) - http://www.wfduk.org/resources/category/environmental-standardmethods-203/tags/bioavailability-assessment-tool-205/tags/metals-181
Croatian: Environment Agency, United Kingdom Metal bioavailability assessment tool (M-BAT) - http://www.wfduk.org/resources/category/environmental-standardmethods-203/tags/bioavailability-assessment-tool-205/tags/metals-181
English: In general terms, as for the benefits, other risks are expected to be the same as for the reference product and have not been evaluated by the CVMP.
Croatian: Općenito gledano, kao i u slučaju koristi, očekuje se da će ostali rizici biti jednaki onima referentnog proizvoda te ih CVMP nije ocijenio.
English: Various RMMs are proposed which are anticipated to reduce the accumulation of zinc.
Croatian: Predloženi su različiti RMM-ovi za koje se očekuje da će smanjiti nakupljanje cinka.
English: Even where manure storage is combined, piglet manure would account for 40% or less of the mixture.
Croatian: Čak i kada se kombinira skladištenje gnojiva, prasiji gnoj ima udjela od za 40% ili manje od mješavine.
English: The most important factors in determining bioavailability (and, hence, ecotoxicity) in soils are soil type and the time between the addition of zinc to soil and toxicity testing (‘ageing').
Croatian: Najvažniji čimbenici u utvrđivanju bioraspoloživosti (te, stoga, ekotoksičnosti) u zemlji su tip zemlje i vrijeme između dodavanja cinka u zemlju i testiranja toksičnosti ("starenja").
English: 6, and was used to refine the risk assessment for Gutal as it is considered appropriate as it can be used for inorganic substances.
Croatian: 6, i korišten je za pročišćavanje ocjene rizika za Gutal budući da se smatralo primjerenim za uporabu za anorganske tvari.
English: Additionally, as the IDMM has been taken into consideration for the EFSA assessment of zinc exposure, it may also be considered relevant for the assessment of veterinary medicinal products in terms of environmental exposure assessment.
Croatian: Nadalje, budući da se IDMM uzeo u obzir za ocjenu EFSA izlaganja cinka, može se također smatrati relevantnim za ocjenu veterinarsko-medicinskih proizvoda u smislu ocjene izlaganja okoliša.
English: Zinc binds strongly to AVS and becomes non-bioavailable, which would allow for making a correction on the exposure assessment for bioavailability of metals in sediment systems (ECHA 2014)
Croatian: Cink se snažno vezuje na AVS i postaje nebioraspoloživ, što bi omogućilo provođenje ispravka o izlaganju ocjene za bioraspoloživot metala u sustavima sedimenta (ECHA 2014)
English: A risk was identified from 2020 for two of 15 surface water scenarios (acidic, sandy soils) and for all 15 sediment scenarios.
Croatian: Rizik je identificiran od 2020. za dvije od 15 scenarija površinskih voda (kisela, pjeskovita tla) , a za svih 15 scenarija sedimenta.
English: In order to limit nutrient loss and eutrophication, Good Agricultural Practice recommends manure should not be spread on vulnerable soils (acidic, freely draining, sandy soils).
Croatian: Kako bi se ograničio gubitak hranjivih tvari i eutrofikacija, dobra poljoprivredna praksa preporučuje da se gnojivo ne treba širiti na ranjiva tla (kisela, pjeskovita tla koja se slobodno dreniraju).
English: The level of accumulation and time dependency for the different environmental compartments were evaluated.
Croatian: Ocijenjena je razina akumulacije i vrijeme ovisnosti o različitim okolišnim dijelovima.
English: Report to the European Food Safety Authority - http://www.efsa.europa.eu/en/supporting/pub/74e.htm
Croatian: Report to the European Food Safety Authority - http://www.efsa.europa.eu/en/supporting/pub/74e.htm prijavljenih primjenom IDMM-a (EFSA, 2012.)
English: Although the PEC values for each compartment cannot be verified because the IDMM is not provided, overall they appear fairly conservative since a reasonable worst case exposure scenario is considered, i.e. continual application of undiluted manure until 2060.
Croatian: Iako se PEC vrijednosti za svaki odjeljak ne mogu potvrditi, jer IDMM nije naveden, načelno se čine prilično konzervativnima, jer je razuman najgori scenarij izloženosti slučaj uzet u obzir, odnosno trajne primjene nerazrijeđenoga gnojiva do 2060
English: 5.3 Environmental properties
Croatian: 5.3 Svojstva okoliša
English: for a better consideration of relevant
Croatian: za bolju razmatranja relevantnih RMM.
English: Although the endpoint data from one study was not of sufficient quality to be used in calculation of the generic PNEC value from which the site-specific PNECs are derived, it is accepted that the omission of the effects data from this single study would not significantly alter the calculated PNEC.
Croatian: Iako podaci završne točke jednog ispitivanja nisu bili dovoljno kvalitetni da bi se koristili u izračunu generičke vrijednosti PNEC-a iz koje bi se izveli PNEC-ovi specifični za lokaciju, prihvaćeno je da izostavljanje podataka o djelovanju iz ovog jednog ispitivanja ne bi značajno izmijenilo izračunati PNEC.
English: Exposure: accumulation, bioavailability and model calculation of zinc concentrations in the environment
Croatian: Izlaganje: akumulacija, bioraspoloživost i izračun modela za koncentracije cinka u okolišu
English: Given that the VICH and CVMP guidelines on the Phase II environmental risk assessment of veterinary medicinal products are not primarily developed for inorganic molecules, many of the assumptions and exposure models described in the guidelines are unsuitable for a substance such as zinc.
Croatian: Uzimajući u obzir da smjernice o VICH-u i CVMP-u za ocjenu rizika okoliša za Fazu II. veterinarskomedicinskih proizvoda nisu primarno razvijene za anorganske molekule, mnoge pretpostavke i modeli izlaganja opisani u smjernicama nisu prihvatljivi za tvari poput cinka.
English: To assess the risk for each compartment following extended application of manure to land, PECs and PNEC values for each FOCUS scenario were compared at three time points (years: 2020, 2040, 2060), using two application rates: a worst case application rate (7 kg zinc ha a-1
Croatian: Da bi se ocijenio rizik za svaki dio nakon produljene primjene gnojiva na zemlji, PEC-ovi i vrijednosti PNEC-a za svaki scenarij FOCUS-a uspoređeni su u tri vremenske točke (godine: 2020., 2040., 2060.), primjenom dvije stope primjene: stopa primjene u najgorem slučaju (7 kg cinka ha a-1
English: Overall, it is apparent that the long-term, continual use of zinc-containing veterinary medicinal products will result in a gradual net input of zinc to the environment.
Croatian: Sve u svemu, očito je da je dugoročna, stalna uporaba veterinarsko-medicinskih lijekova koji sadržavaju cink rezultirat će postupnim neto unosom cinka u okoliš.
English: Gutal contains zinc oxide as an active substance.
Croatian: Gutal sadrži cinkov oksid kao djelatnu tvar.
English: , as indicated in the CVMP reflection paper on RMMs related to the environmental risk assessment of veterinary medicinal products
Croatian: , kao što je navedeno u dokumentu CVMP-a koji se osvrće na RMMove povezane s procjenom rizika za okoliš veterinarsko-medicinskih lijekova
English: Concerning sediment PECs particularly, accumulation factors are not considered (e.g. deposition, re-suspension, and burial of zinc), it is assumed that suspended sediments are representative of the deposited sediment, and no account is made for acid volatile sulfide levels.
Croatian: . Što se tiče sedimenta PEC-ova posebno, faktori akumulacije nisu uzeti u obzir (npr. taloženje, ponovna suspenzija i zakapanje cinka), pretpostavlja se da su suspendirani sedimenti reprezentativni za deponirani sediment, a u obzir nisu uzete koncentracije kiselih volatilnih sulfida.
English: Finally, the SPC advises compliance with measures taken by local/national authorities to prevent manure entering waters and excessive leakage of minerals with the implementation of a buffer zone.
Croatian: Naposljetku, SPC savjetuje poštivanje mjera poduzetih od strane lokalnih / nacionalnih tijela kako bi se spriječilo da gnojivo uđe u vode i prekomjerno istjecanje minerala s primjenom tampon zone.
English: Risks were identified during the decentralised procedure by Belgium, France and the Netherlands who considered that the marketing authorisation of Gutal may present a potential serious risk to the environment and that the risk mitigation measures (RMMs) proposed to control the risk are inadequate to control or prevent continuous zinc accumulation and, in addition, they are not feasible to implement to all pig farms.
Croatian: Rizici su identificirani tijekom decentraliziranog postupka provedenog od strane Belgije, Francuske i Nizozemske, koje su zaključke da izdavanje odobrenja za stavljanje u promet VMP Gutal može predstavljati potencijalne ozbiljne rizike za okruženje te da su mjere za smanjivanje rizika (RMM-ovi) predloženi za kontrolu rizika neprimjereni kako bi kontrolirali ili spriječili kontinuiranu akumulaciju cinka i, nadalje, njihova implementacija nije moguća u svih svinjskih farmi.
English: For two of the FOCUS scenarios (acidic, sandy soils) the risk quotients (RQs) are >1 for both loading rates at all time points.
Croatian: U slučaju dva od scenarija FOCUS-a (kisela, pjeskovita tla), koeficijenti rizika (KR) bili su >1 za obje stope punjenja u svim vremenskim točkama.
English: A risk was identified for all FOCUS sediment scenarios, at both loading rates and at each time point.
Croatian: Rizik je identificiran za sve scenarije sedimentacije FOCUS-a, i to kako u obje stope punjenja tako i u svakoj vremenskoj točki.
English: Despite the data gap, it may be accepted that such a measure would, most likely, reduce run-off of zinc to watercourses.
Croatian: Unatoč jaza podataka može se prihvatiti da bi takva mjera, najvjerojatnije, smanjila otjecanja cinka u vodotoke.
English: At the time of the zinc EU RAR (2010) there were too few effects or exposure data to be able to account for the effect of these two parameters (AVS/SEM) on zinc bioavailability in sediments.
Croatian: U trenutku provođenja EU RAR (2010.) za cink bilo je prisutno premalo učinaka ili podataka o izlaganju da bi se moglo uzeti u obzir djelovanje ova dva parametra (AVS/SEM) na bioraspoloživost cinka u sedimentima.
English: Additionally, as the model was not made available to the CVMP, the relevance of the default input parameters could not be assessed and the model could not be run using data on specific application rates for zinc.
Croatian: Nadalje, budući da model nije učinjen dostupnim CVMP-u, relevatnost ulaznih parametara nije se mogla ocijeniti, te se model nije mogao izvršiti primjenom podataka o specifičnim stopama primjene za cink.
English: Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium
Croatian: Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgija
English: The CVMP concluded that the concerns expressed by France and the Netherlands should not prevent the granting of a marketing authorisations provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc, are added to the product information.
Croatian: CVMP je zaključio da zabrinutosti koje su iznijele Francuska i Nizoztmenska ne smiju spriječiti izdavanje odobrenja za stavljanje VMP-a u promet ukoliko se preporučene mjere za smanjivanje rizika, za koje se očekuje da će smanjiti nakupljanje cinka, uvrste u informacije o proizvodu.
English: The IDMM predicts the long-term mass balance of metals, with defined inputs (e.g. veterinary medicinal products usage) and outputs (e.g. crop off-take, ageing), and concludes that zinc will accumulate in soil following continual application of treated manure with acidic sandy soils being most vulnerable as these soils have a tendency to accumulate zinc more rapidly than other type of soils and will also have a higher drainage and run-off of zinc to surface water.
Croatian: IDMM predviđa dugoročnu ravnotežu mase metala, s definiranim unosima (primjerice primjena veterinarskomedicinskog lijeka) i iznosa (primjerice preuzimanje kroz usjev, starenje), i zaključuje da će se cink akumulirati u zemlji nakon kontinuirane primjene tretiranog gnojiva pri čemu su kisela, pjeskovita tla najpodložnija budući da su ova tla sklona akumulirati cink brže od drugih tipova tla te imaju također veću stopu drenaže i istjecanja cinka u površinske vode.
English: In order to better indicate the risks posed at application rates considered particularly relevant by the use of Gutal of 8.2 kg zinc ha y-1
Croatian: Kako bi se bolje ukazali rizici prikazani u stopama primjene za koje se smatralo da su posebno važni na temelju primjene VMP-a Gutal jačine 8,2 kg cinka ha y-1
English: Undiluted manure from treated piglets should not be applied to land.
Croatian: Nerazrijeđeno gnojivo od tretiranih odojaka ne smije se koristiti na tlu.
English: There are a number of uncertainties associated with use of the IDMM for predicting the environmental exposure of zinc from use in veterinary medicinal products, such as the effects of hydrology, dissolved organic carbon and metal aging.
Croatian: Prisutan je niz nesigurnosti povezanih s primjenom IDMM-a za predviđanje okolišnog izlaganja cinka primjenjenog u veterinarsko-medicinskim proizvodima, poput djelovanja hidrologije, razgrađenog organskog ugljika i starenja metala.
English: It is believed that bioavailability of metals in sediment can be predicted by measuring the acid volatile sulphide (AVS) and the simultaneously extracted metal (SEM) contents of sediments.
Croatian: bioraspoloživost metala u sedimentu može predvidjeti mjerenjem udjela kiselinskih volatilnih sulfida (AVS-a) i istovremeno ekstrahiranih metala (SEM-a) sedimenta.