natgillin/translations-raw huggingface dataset:
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.
Kombinacija konzervativne vrednosti PNEC (brez upoštevanja biološke uporabnosti) in PEC bi lahko privedla do precenjenega tveganja zaradi cinka v sedimentih.
This referral was raised due to concerns regarding the environmental risk assessment.
Ta napotitveni postopek je bil sprožen zaradi zadržkov v zvezi z oceno tveganja za okolje.
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.
Ob stalnem nanašanju gnoja zdravljenih živali naj bi bilo do leta 2060 tveganje za okolje (določeno z vrednostmi KT > 1) prisotno pri 4 od 19 scenarijev za tla, 5 od 15 scenarijev za površinske vode in pri vseh 15 scenarijih za sedimente.
Gutal 1000 g/kg premix for medicated feeding stuff for piglets (thereafter called ‘Gutal') contains zinc oxide as an active substance.
Gutal 1000 g/kg predmešanica za zdravilno krmno mešanico za prašičke (v nadaljnjem besedilu „Gutal“) vsebuje zdravilno učinkovino cinkov oksid.
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.
Da bi zmanjšali tveganje, povezano s kopičenjem cinka v različnih delih okolja, je bilo predlagano, da se v informacije o zdravilu vključi več ukrepov za zmanjšanje tveganja.
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.
7, potrebna ekstrapolacija, pri čemer razmerje med stopnjo obremenitve s cinkom in vrednostmi PEC, izračunanimi z modelom IDMM, ni linearno, zaradi česar bi bila lahko vprašljiva veljavnost ekstrapoliranih vrednosti PEC pri največjih odmerkih cinka.
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.
V okviru tega postopka je moral odbor CVMP presoditi, ali bi uporaba zdravila Gutal za uporabo v veterinarski medicini, ki vsebuje zdravilno učinkovino cinkov oksid, kovinsko snov, ki je opredeljena kot zelo strupena za vodne organizme, lahko predstavljala resno tveganje za okolje in ali so v tem primeru ukrepi za zmanjšanje tveganja ustrezni, da bi lahko z njimi zadovoljivo obvladali in/ali preprečili tveganje za okolje.
Zinc is persistent in soils and may accumulate in sediments.
Cink vztraja v tleh in se lahko zbira v sedimentih.
European Union Risk Assessment Report (EU RAR) on zinc (2010)http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/15064/1/lbna24587enn.pdf Environment Agency.
European Union Risk Assessment Report (EU RAR) on zinc (2010)http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/15064/1/lbna24587enn.pdf določitev okoljskega standarda kakovosti
Manure from treated piglets should not be spread on vulnerable soil types, which have been identified as freely draining, acidic (pH ≤6), sandy soils.
Gnoja zdravljenih pujskov ne širiti na ranljivih vrstah tal, ki so prepoznana kot izsuševana, kisla (pH ≤6) in peščena tla.
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.
Model IDMM napove dolgoročno masno bilanco kovin na podlagi opredeljenega vnosa (npr. uporaba zdravil za uporabo v veterinarski medicini) in odvzema (odvzem snovi s pridelki, staranje) in je predvidel, da se bo cink ob stalnem nanašanju gnoja kopičil v tleh, pri čemer bodo najbolj ranljiva kisla peščena tla, saj se v teh tleh cink kopiči hitreje kot v drugih vrstah tal, zanje pa je značilno tudi večje odvodnjavanje in odtekanje cinka v površinske vode.
Undiluted manure from treated piglets should not be applied to land.
Nerazredčeni gnoj zdravljenih živali ni dovoljeno nanašati na zemljo.
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).
Biološka uporabnost zato ni bila upoštevana pri izračunih izpostavljenosti (določanju vrednosti PEC), kar pomeni, da v oceni tveganja ni bil upoštevan biološko uporaben delež cinka, temveč skupne koncentracije cinka (biološko uporabnega in neuporabnega).
• 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.
• vendar pa je ob upoštevanju razprave o okoljskih nevarnostih, povezanih z uporabo zdravila Gutal, in ugotovljenega tveganja za okolje, povezanega z uporabo zdravil za uporabo v veterinarski medicini, ki vsebujejo cink, primerno, da se sprejmejo dodatni ukrepi za obvladovanje tveganja, ki bodo zmanjšali kopičenje cinka v tleh, vodah in sedimentih.
Report to the European Food Safety Authority - http://www.efsa.europa.eu/en/supporting/pub/74e.htm
Report to the European Food Safety Authority - http://www.efsa.europa.eu/en/supporting/pub/74e.htm ki vsebujejo cink, izračunana iz vnaprej določenih stopenj obremenitve v modelu IDMM.
Effect data
Podatki o učinku
Dilution with manure of untreated animals or sows is required so that the total amount of treated piglet manure is as low as possible and is never exceeding 40%, the ratio when manure of weaned piglets and sows is stored together.
Potrebno je redčenje z gnojem nezdravljenih živali ali svinj, tako da je skupni znesek gnoja zdravljenih pujskov čim nižji in nikoli ne presega 40 odstotkov, kar je razmerje, ko se gnoj odstavljenih pujskov in svinj shranjuje skupaj.
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.
faze za zdravila za uporabo v veterinarski medicini niso primarno razvite za anorganske molekule, veliko predpostavk in modelov izpostavljenosti, opisanih v smernicah, ni primernih za snov, kot je cink.
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.
Poleg tega je bilo ocenjeno, da je model IDMM glede na to, da ga je upoštevala tudi agencija EFSA pri ocenjevanju izpostavljenosti cinku, primeren za oceno zdravil za uporabo v veterinarski medicini za pridobitev ocene izpostavljenosti okolja.
A risk to the environment has been identified due to accumulation of zinc, particularly to the aquatic compartment.
Ugotovljeno je bilo tveganje za okolje zaradi kopičenja cinka, zlasti tveganje za vodno okolje.
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.
Znano je, da zaradi fizikalnih in kemijskih lastnosti cinka (nehlapen in nerazgradljiv) stalno nanašanje gnoja zdravljenih živali na zemljo v okviru intenzivne prašičereje povzroči postopno povečanje koncentracije cinka v humusu, sčasoma pa tudi v drugih zadevnih delih okolja.
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.
Po drugi strani obstaja več nejasnosti, povezanih z uporabo modela IDMM za napovedovanje izpostavljenosti okolja cinku zaradi uporabe zdravil za uporabo v veterinarski medicini, med drugim glede hidroloških vplivov ter vpliva organskega ogljika in staranja kovin.
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.
V okviru ukrepov za zmanjšanje tveganja in ob upoštevanju potrebe po preprečevanju kopičenja cinka v delih okolja v koncentracijah nad vrednostmi PNEC je bilo predlagano, da se nerazredčen gnoj zdravljenih prašičkov ne bi smel nanašati na zemljo in da bi se gnoj zdravljenih živali razredčil z gnojem nezdravljenih živali, tako da bi gnoj zdravljenih živali predstavljal največ 40 % celotne mešanice.
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.
Vendar pa v nasprotju s pristopi iz smernic CVMP/VICH model IDMM napove usodo in obnašanje cinka v tleh, razlikuje območja glede na občutljivost za cink ter upošteva staranje cinka, vire morebitnih strupenih snovi v okolju in količino naravno prisotnih snovi v okolju.
In the aquatic compartment, zinc bioavailability in water has been predicted using the Metal Bioavailability Assessment Tool (United Kingdom Environment Agency)
Za vodno okolje je bila predvidena biološka uporabnost cinka v vodi določena s pomočjo orodja za oceno biološke uporabnosti kovin (Agencija Združenega kraljestva za okolje)
For two of the FOCUS scenarios (acidic, sandy soils) the risk quotients (RQs) are >1 for both loading rates at all time points.
Pri dveh scenarijih v modelu FOCUS (kisla, peščena tla) so bili količniki tveganja (KT) > 1 pri obeh stopnjah obremenitve in ob vseh časovnih točkah.
Environment Agency, United Kingdom for zinc), and were used by the applicant to establish different PNECs for each environmental compartment.
2 za cink), ki jih je predlagatelj uporabil za določitev različnih vrednosti PNEC za vsak del okolja.
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.
Orodje za oceno biološke uporabnosti kovin (Metal Bioavailability Assessment Tool) zahteva manj vhodnih podatkov za napoved biološke uporabnosti cinka v vodi kot biotski ligandski model in se lahko uporabi za izračun vrednosti PNEC za določeno območje.
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.
Pri zemeljskem in vodnem delu okolja je bilo tveganje (KT > 1) ugotovljeno pri 4 od 19 scenarijev za odmerek v najslabšem možnem primeru in pri 5 od 15 scenarijev za manjši odmerek od leta 2060 naprej.
4 which incorporates parameters relevant to determine soil zinc bioavailability, such as pH, organic and clay content, and the cation exchanged capacity.
4, ki vključuje parametre, pomembne za določitev biološke uporabnosti cinka v tleh, kot so pH, vsebnost organskih snovi in gline ter kationska izmenjalna kapaciteta.
There is some uncertainty associated with the scale of this risk.
Obseg tega tveganja ni povsem jasen.
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.
Kljub tem nejasnostim je bilo ob odsotnosti boljše alternative ocenjeno, da se z modelom IDMM lahko pridobi sprejemljiva ocena tveganja, ki ga za okolje predstavlja uporaba zdravila Gutal.
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.
V tem napotitvenem postopku niso ocenjevali kakovosti, varnosti za ciljne živali, varnosti za uporabnika, vpliva na razvoj protimikrobne odpornosti, ostankov in učinkovitosti, saj referenčna država članica ni priglasila nobenega pomisleka.
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).
Prvi ukrep je, da je treba nerazredčen gnoj zdravljenih prašičkov pred nanosom na zemljo razredčiti (tako da gnoj zdravljenih živali predstavlja največ 40 % celotne mešanice).
Overall summary of the scientific evaluation of Gutal 1000 g/kg premix for medicated feeding stuff for piglets (see Annex I)
Splošen povzetek znanstvenega vrednotenja zdravila Gutal 1000 g/kg predmešanica za zdravilno krmno mešanico za prašičke (glejte Prilogo I)
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.
Rezultati ocene tveganja za okolje za zdravilo Gutal so skladni z zaključki iz poročila agencije EFSA za cink, da obstaja morebitna nevarnost za okolje, povezana z vodnim delom okolja (vključno s sedimenti), pri čemer so najbolj ranljiva kisla, peščena in dobro propustna tla.
Various RMMs are proposed which are anticipated to reduce the accumulation of zinc.
Predlaganih je bilo več ukrepov za zmanjšanje tveganja, ki naj bi zmanjšali kopičenje cinka.
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.
Čeprav je bilo ugotovljeno, da imajo predlagani ukrepi za zmanjšanje tveganja pomanjkljivosti, niti ni mogoče povsem jasno določiti, v kolikšni meri bodo zmanjšali tveganje za okolje, je mogoče pričakovati, da bodo upočasnili kopičenje cinka v okolju.
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.
V tem napotitvenem postopku niso ocenjevali kakovosti, varnosti za ciljne živali, varnosti za uporabnika, vpliva na razvoj protimikrobne odpornosti in ostankov, saj referenčna država članica ni priglasila nobenega pomisleka.
Amendments in the relevant sections of the Summary of Product Characteristics and package leaflet
Dopolnila, ki se vključijo v ustrezna poglavja povzetka glavnih značilnosti zdravila in navodila za uporabo
The product should not be used on farms where dilution of manure is not possible.
Zdravilo se ne sme uporabljati na kmetijah, kjer redčenje gnoja ni mogoče.
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.
Zaradi naravnih lastnosti cinka (nehlapen in nerazgradljiv) možnost, da bi bile zaradi dolgotrajnejšega stalnega nanašanja gnoja zdravljenih živali na zemljo sčasoma presežene vrednosti PNEC, predstavlja veliko nevarnost za okolje, zlasti za najranljivejše vrste tal (kisla, dobro propustna, peščena tla) in organizme vodnih delov okolja.
Zinc may accumulate in soil following continual application of manure from treated animals; with acidic sandy soils being most vulnerable.
Cink se lahko zbira v prsti po stalni uporabi gnoja zdravljenih živali; najbolj občutljive so kisla, peščena tla.
Scientific conclusions and grounds for the granting of the marketing authorisation for Gutal 1000 g/kg premix for medicated feeding stuff for piglets
Znanstveni zaključki in podlaga za odobritev dovoljenja za promet z zdravilom Gutal 1000 g/kg predmešanica za zdravilno krmno mešanico za prašičke
The product should not be used on farms where appropriate dilution of manure is not possible.
Zdravilo se ne sme uporabljati na kmetijah, kjer gnoja ni mogoče ustrezno razredčiti.
The applicant Huvepharma NV submitted a marketing authorisation application, via the decentralised procedure, for Gutal according to Article 13(1) Directive 2001/82/EC, referring to the reference product ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff authorised in the United Kingdom.
Predlagatelj Huvepharma NV je predložil vlogo za pridobitev dovoljenja za promet z zdravilom Gutal po decentraliziranem postopku v skladu s členom 13(1) Direktive 2001/82/ES, ki se sklicuje na referenčno zdravilo ZincoTec Zinc Oxide 100 % predmešanica za zdravilno krmno mešanico, ki je odobreno v Združenem kraljestvu.
For each compartment (soil, water and sediment), zinc bioavailability is dependent on various biotic and abiotic factors.
Biološka uporabnost cinka v posameznem delu okolja (v tleh, vodi in usedlinah) je odvisna od različnih biotskih in abiotskih dejavnikov.
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.
Kljub tem nejasnostim se ob upoštevanju narave zdravilne učinkovine, ki je anorganska molekula, in težav pri oceni tveganja za okolje za spojino, ki ni obravnavana v veljavnih smernicah CVMP/VICH, ki so jih opažali skozi celoten postopek obravnavanja vloge, lahko zaključi, da ocenjene vrednosti PEC, ekstrapolirane iz izhodnih podatkov modela IDMM, zadovoljivo odražajo izpostavljenost okolja, da se lahko uporabijo pri opredelitvi tveganja za zdravilo Gutal.
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.
Podatki, specifični za cink, trenutno niso na voljo, vendar se lahko kot vodilo uporabi sposobnost varovalnih pasov, da zmanjšajo obremenitev suspendiranih sedimentov, ki v glavnem prenašajo cink v lokalne vodotoke.
RQs have been extrapolated (linearly) from application rates of 4 and 7 kg zinc ha a-1
, so (linearno) ekstrapolirali količnike tveganja iz odmerkov 4 in 7 kg cinka ha a-1
, as indicated in the CVMP reflection paper on RMMs related to the environmental risk assessment of veterinary medicinal products
kot je navedeno v strokovni presoji ukrepov za zmanjšanje tveganja, povezanih z oceno tveganja za okolje za zdravila za uporabo v veterinarski medicini, odbora CVMP
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
Za boljšo obravnavo zadevnih ukrepov za zmanjšanje tveganja je predlagatelj zagotovil vrednosti KT za alternativne odmerke z linearno ekstrapolacijo rezultatov, dobljenih z modelom IDMM za odmerka cinka 4 in 7 kg ha a-1
Gutal contains zinc oxide as an active substance.
Zdravilo Gutal vsebuje zdravilno učinkovino cinkov oksid.
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.
Kljub nejasnostim v zvezi z linearno ekstrapolacijo rezultatov, dobljenih z modelom IDMM, je bilo ocenjeno, da vrednosti PEC, ekstrapolirane iz izhodnih podatkov modela IDMM, zadovoljivo odražajo izpostavljenost okolja, da se lahko uporabijo pri opredelitvi tveganja za zdravilo Gutal.
) and a lower application rate (4 kg zinc ha a-1
) in manjši odmerek cinka (4 kg ha a-1
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)
Zato je bil za izboljšanje ocene tveganja za zdravilo Gutal uporabljen model, ki ga je agencija EFSA uporabila za oceno izpostavljenosti okolja, povezane z uporabo cinkovega oksida kot krmnega dodatka, tj. vmesni dinamični model za kovine (Intermediate Dynamic Model for Metal - IDMM), ki so ga razvili Monteiro in sodelavci (2010) saj je bil ta model ocenjen kot ustrezen, ker se lahko uporablja za anorganske snovi.
Grounds for the granting of the marketing authorisations for Gutal 1000 g/kg premix for medicated feeding stuff for piglets
Podlaga za odobritev dovoljenja za promet z zdravilom Gutal 1000 g/kg predmešanica za zdravilno krmno mešanico za prašičke
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.
Zadnji ukrep pa je priporočilo v povzetku glavnih značilnosti zdravila o upoštevanju ukrepov lokalnih/nacionalnih organov oblasti, ki določajo varovalni pas, ki preprečuje vnos gnoja v vode ter čezmerno odtekanje mineralov.
mineral phases, e.g. iron (oxy)hydroxides and manganese oxides, as well as the organic matter content in sediments.
Ostala parametra, ki vplivata na (zmanjšujeta) biološko uporabnost cinka v sedimentih, sta prisotnost oborjenih mineralnih faz, npr. železovih (oksi)hidroksidov in manganovih oksidov, ter vsebnost organskih snovi v sedimentih.
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.
sulfida (acid volatile sulphide - AVS) in sočasno ekstrahiranih kovin (simultaneously extracted metalSEM) v sedimentih.
In soil, properties such as pH, organic carbon content, cation exchange capacity, and clay content determine bioavailability in the terrestrial compartment.
Kar zadeva tla, je biološka uporabnost v tleh odvisna od lastnosti, kot so pH, vsebnost organskega ogljika, kationska izmenjalna kapaciteta in vsebnost gline.
IDMM (EFSA, 2012)
Vendar pa je pri odmerkih, večjih od tistih, izračunanih z modelom IDMM (EFSA, 2012)
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.
Kar zadeva vrednosti PEC za sedimente, niso upoštevani dejavniki kopičenja (npr. usedanje, resuspenzija in zakopavanje cinka),
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.
Primeren ukrep za zmanjšanje tveganja bi bilo tudi priporočilo, da se je treba izogibati trošenju gnoja po istem predelu zemlje več let zapored, s čimer bi upočasnili kopičenje cinka.