FrancophonIA/ELRC3.0 huggingface dataset:
English: When spreading manure from treated animals, the minimum distance to surface water as defined in the national or local regulations has to be strictly respected, and at least a minimum buffer zone of 3 m applied, because the manure contains zinc which may cause adverse effects in the aquatic environment.
Danish: Ved spredning af gylle fra behandlede dyr skal den mindste afstand til overfladevand, som defineret i de nationale eller lokale regler, strengt respekteres, og en stødpudezone på minimum 3 m anvendes, da gyllen indeholder zink, som kan forårsage skader i vandmiljøet.
English: A risk to the environment has been identified due to accumulation of zinc, particularly to the aquatic compartment.
Danish: Der er identificeret en risiko for miljøet som følge af akkumulering af zink, navnlig for det akvatiske delmiljø.
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.
Danish: Da der er taget højde for IDMM i EFSA's vurdering af zinkeksponering, kan den desuden være relevant for vurderingen af veterinærlægemidler med hensyn til miljøeksponeringsvurderinger.
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).
Danish: 3, en brugervenlig udgave af den såkaldte Biotic Ligand Model, som er en model, der anvendes til at beregne de biotilgængelige metaller for forskellige akvatiske arter (alger, dafnier og fisk), og som er blevet anvendt og er velrapporteret i en lang række fagfællebedømte undersøgelser af zink, samt dataene i EU RAR for zink (2010).
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.
Danish: CVMP anbefalede derfor udstedelse af markedsføringstilladelse for de veterinærlægemidler, som er anført i bilag I med ændringer til referencemedlemsstatens produktresumé og indlægsseddel.
English: At a site-specific level, PNEC bioavailability corrections in sediment as a result of AVS/SEM content in sediment, can be made if the necessary data are available; however, such data are scarce.
Danish: Stedsspecifikt kan der foretages korrektioner for biotilgængelighed af PNEC i sediment som følge af indholdet af AVS/SEM i sediment, såfremt de nødvendige data er til rådighed, men sådanne data er knappe.
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
Danish: For bedre at kunne angive risiciene ved de forskellige doseringer, som anses for at være særlig relevante ved brug af Gutal med 8,2 kg zink ha y-1
English: Effect data
Danish: Effektdata
English: Metal bioavailability assessment tool (M-BAT) - http://www.wfduk.org/resources/category/environmental-standardmethods-203/tags/bioavailability-assessment-tool-205/tags/metals-181
Danish: 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: Although this RMM would most likely reduce the risk for all compartments, a risk for surface water and, particularly, sediment may remain.
Danish: Selv om denne risikobegrænsningsforanstaltning sandsynligvis ville sænke risikoen for alle delmiljøer, vil der fortsat være en risiko for overfladevand og navnlig sediment.
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)
Danish: Zink binder kraftigt til AVS og bliver ikkebiotilgængeligt, hvilket bør afstedkomme en korrektion i eksponeringsvurderingen for metallers biotilgængelighed i sedimentsystemer (ECHA 2014)
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.
Danish: menes, at metallers biotilgængelighed i sediment kan beregnes ved at måle syreflygtigt sulfid (AVS) og de samtidigt ekstraherede metallers (SEM) indhold i sedimenter.
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.
Danish: Selv om endepunktdataene fra den ene undersøgelse ikke var af tilstrækkelig høj kvalitet til at blive anvendt i beregningen af den generiske PNEC-værdi, som de stedsspecifikke PNEC'er udledes af, accepteres det, at det ikke ville ændre den beregnede PNEC betydeligt, hvis effektdataene ikke blev medtaget i denne ene undersøgelse.
English: A risk was identified from 2020 for two of 15 surface water scenarios (acidic, sandy soils) and for all 15 sediment scenarios.
Danish: Der blev identificeret en risiko fra 2020 for to af 15 scenarier for overfladevand (sur sandjord) og for alle 15 scenarier for sediment.
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.
Danish: Valideringsdataene for IDMM er begrænsede, men dog tilstrækkelige til at stole på, at modellen kan anvendes til at opnå en vidtstrakt, pragmatisk vurdering af miljøets eksponering for zink.
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).
Danish: Zinks biotilgængelighed, og dermed miljørisikoen, varierer mellem jordtyper og miljømæssige forhold (f.eks opløst organisk kulstof, kalcium og pH).
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.
Danish: IDMM beregner den langsigtede massebalance af metaller med definerede input (f.eks. anvendelse af veterinærlægemidler) og output (f.eks. aftagning af afgrøder, ældning) og konkluderer, at zink akkumulerer i jord efter kontinuerlig anvendelse af behandlet gødning, idet sur sandjord er mest sårbar, da denne jord har en tendens til at akkumulere zink hurtigere end andre typer jord og også vil have en større dræning og afstrømning af zink til overfladevand.
English: Various RMMs are proposed which are anticipated to reduce the accumulation of zinc.
Danish: Der er foreslået forskellige risikobegrænsningsforanstaltninger, som ventes at reducere akkumuleringen af zink.
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.
Danish: Der findes i øjeblikket ikke zinkspecifikke data, men stødpudezoner, som reducerer suspenderede sedimenter, som er den overvejende transportrute for zink til de lokale vandløb, kan anvendes som indikator.
English: Moreover, validation of the IDMM has been performed by the comparison of model predictions against published monitoring data for zinc applications.
Danish: Valideringen af IDMM er desuden foretaget ved at sammenligne modelberegninger og offentliggjorte overvågningsdata for anvendelser af zink.
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.
Danish: For at sænke risikoen fra akkumulering af zink i delmiljøer foreslås det at indarbejde en række risikobegrænsningsforanstaltninger i produktoplysningerne.
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.
Danish: I denne procedure blev CVMP anmodet om at overveje, om brugen af Gutal, som er et veterinærlægemiddel, der som aktivt stof indeholder zinkoxid, der er et metalstof, som klassificeres som meget giftigt for vandlevende organismer, kan udgøre en mulig alvorlig risiko for miljøet, og i så fald om der kan overvejes relevante risikobegrænsningsforanstaltninger til at styre og/eller forebygge miljørisiciene på tilstrækkelig vis.
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.
Danish: Kombinationen af konservativ PNEC (uden hensyntagen til biotilgængelighed) og PEC kan resultere i en overvurdering af risikoen som følge af zink i sedimenter.
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.
Danish: Efter kontinuerlig anvendelse af gødning fra behandlede dyr ses inden 2060 en miljørisiko (defineret af RQ-værdier >1) i fire ud af 19 scenarier for jord, fem ud af 15 scenarier for overfladevand og hvert af de 15 scenarier for sediment.
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).
Danish: Der blev derfor ikke taget højde for biotilgængelighed i eksponeringsberegningerne (der lå til grund for PEC'erne), hvilket medførte en risikovurdering, der ikke tog højde for den biotilgængelige del af zink, men i stedet de samlede zinkkoncentrationer (biotilgængelige og ikkebiotilgængelige).
English: Nonetheless, for each compartment, risks have been identified for some scenarios at each application rate investigated.
Danish: Ikke desto mindre er der for hvert delmiljø identificeret visse scenarier for hver af de undersøgte doseringer.
English: Zinc is persistent in soils and may accumulate in sediments.
Danish: Zink er persistent i jord og kan ophobes i sedimenter.
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.
Danish: Resultaterne af miljørisikovurderingen for Gutal afspejler EFSA's konklusion om zink, nemlig at der er en mulig miljømæssig betænkelighed vedrørende det akvatiske delmiljø (herunder sediment), idet sur veldrænet sandjord er mest sårbar over for disse processer.
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
Danish: For at vurdere risikoen for de enkelte delmiljøer efter udbredt anvendelse af gødning på jord blev PEC'er og PNEC-værdier for de enkelte FOCUS-scenarier sammenlignet på tre tidspunkter (år 2020, 2040 og 2060) ved hjælp af to doseringer: den værst tænkelige dosering (7 kg zink ha a-1
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.
Danish: Og endelig råder produktresuméet til at følge de foranstaltninger, som lokale/nationale myndigheder har truffet for at forebygge, at gødning kommer ud i vandløb, og at der lækkes for mange mineraler, ved at indføre stødpudezoner.
English: Zinc is very toxic to aquatic organisms and is persistent in soils and sediments.
Danish: Zink er meget giftigt for vandlevende organismer og er persistent i jord og sedimenter.
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.
Danish: Der er en vis usikkerhed forbundet med brug af IDMM til beregning af den miljømæssige eksponering af zink fra brug i veterinærlægemidler som f.eks. virkningen af hydrologi, opløst organisk kulstof og metals ældning.
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.
Danish: For så vidt angår risikobegrænsningsforanstaltninger, og da det er nødvendigt at forebygge akkumulering af zink i delmiljøer, der overstiger PNEC-niveauerne, er det blevet foreslået, at ufortyndet gødning fra behandlede smågrise ikke bør anvendes på jord, og at gødning fra behandlede dyr fortyndes med gødning fra ubehandlede dyr, så den behandlede gødning udgør 40 % eller mindre af den samlede blanding.
English: Huvepharma NV Uitbreidingstraat 80 2600 Antwerp Belgium
Danish: Huvepharma NV Uitbreidingstraat 80 2600 Antwerpen Belgien
English: Any unused veterinary medicinal product or waste material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinære lægemidler samt affald, der stammer fra sådanne veterinærlægemidler, skal destrueres i henhold til lokale retningslinjer.
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.
Danish: Hvor der således findes for meget AVS, og der dannes zinksulfider, kan PNEC-værdien overskrides væsentligt, inden der observeres nogen negative virkninger.
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.
Danish: Der findes kun få underliggende feltundersøgelser om akkumulering af zink i jord, og de tilgængelige data kan være både tvetydige og mangle troværdighed, da de f.eks. ikke altid afspejler det forventede anvendelsesmønster for gødning efter brug af zinkoxid i svineopdræt eller jordtyper, der er repræsentative for hele Europa.
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.
Danish: Trods denne usikkerhed og i mangel af et bedre alternativ menes det, at IDMM kan anvendes til at opnå en rimelig vurdering af den miljørisiko, som brug af Gutal udgør.
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.
Danish: • Efter at have behandlet de miljømæssige betænkeligheder ved anvendelse af Gutal og efter at have identificeret en miljørisiko ved brug af veterinærlægemidler, der indeholder zink, synes det imidlertid at være passende at træffe yderligere risikobegrænsningsforanstaltninger for at reducere akkumulering af zink i delmiljøerne for jord, vand og sediment.
English: Overall summary of the scientific evaluation of Gutal 1000 g/kg premix for medicated feeding stuff for piglets (see Annex I)
Danish: Samlet resumé af den videnskabelige evaluering af Gutal 1000 g/kg premix til foderlægemiddel til smågrise (se bilag I)
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
Danish: Ansøgeren har genereret RQ-værdier for alternative doseringer via lineær ekstrapolering af IDMMresultaterne for doseringer på 4 og 7 kg zink ha a-1
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.
Danish: 7, er der behov for ekstrapolering, og forholdet mellem zinkbelastningen og PEC-værdierne beregnet af IDMM er ikke lineært, hvilket kan så tvivl om gyldigheden af de ekstrapolerede PEC'er ved den højeste zinkdosering.
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.
Danish: Belgien, Frankrig og Nederlandene identificerede risici i den decentrale procedure og mente, at en markedsføringstilladelse til Gutal kunne indebære en mulig alvorlig risiko for miljøet, og at de foreslåede risikobegrænsningsforanstaltninger til styring af risikoen ikke var tilstrækkelige til at styre eller forebygge kontinuerlig akkumulering af zink, og at de endvidere ikke kunne implementeres på alle svinebrug.
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.
Danish: Værktøjet til vurdering af metallers biotilgængelighed kræver færre data for at kunne beregne zinks biotilgængelighed i vand end ovennævnte Biotic Ligand Model og kan anvendes til at beregne stedsspecifikke PNEC'er.
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.
Danish: Det er anerkendt, at zinks fysisk-kemiske egenskaber (ikkeflygtig og ikkenedbrydelig) betyder, at kontinuerlig anvendelse af gødning fra behandlede dyr på jord i forbindelse med intensivt svineopdræt vil medføre en gradvis forøgelse af zinkkoncentrationen i de øverste jordlag efterfulgt af en forøgelse i andre relevante delmiljøer over tid.
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.
Danish: Værktøjet til vurdering af metallers biotilgængelighed er baseret på resultaterne fra ovennævnte Biotic Ligand Model for zink og det datasæt, som anvendes til at udlede miljøkvalitetsstandarden for zink, og kræver kun inputdata for vands pH-værdi, opløst organisk kulstof og opløst calciumkoncentration, men tager ikke højde for tilstedeværelsen af andre ioner, der kan påvirke typebestemmelsen af zink og dermed biotilgængeligheden.
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.
Danish: Trods denne usikkerhed og under hensyntagen til det aktive stofs natur som et uorganisk molekyle og vanskelighederne i hele ansøgningsproceduren med hensyn til at vurdere miljørisikoen for en blanding, der ligger "uden for" de aktuelle CVMP/VICH-retningslinjer, kan det accepteres, at de skønnede PEC-værdier ekstrapoleret af IDMM-output giver et rimeligt billede af miljøeksponeringen, som kan anvendes i risikokarakteriseringen af Gutal.
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.
Danish: I delmiljøet for jord og det akvatiske delmiljø blev der fundet en risiko (RQ >1) i fire ud af 19 scenarier og i fem ud af 15 scenarier fra 2060 og fremefter for henholdsvis den værst tænkelige og den lavere dosering.
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.
Danish: Navnlig med hensyn til sediment-PEC'er tages der ikke hensyn til akkumuleringsfaktorer (f.eks. deponering, resuspension og nedgravning af zink), idet det antages, at suspenderede sedimenter er repræsentative for deponerede
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.
Danish: Som følge af zinks iboende egenskaber (ikkeflygtig og ikkenedbrydelig) er muligheden for, at PNEC'er på et tidspunkt overskrides som følge af kontinuerlig anvendelse af gødning fra behandlede dyr på jord over en længere periode, en betydelig miljømæssig bekymring, navnlig med hensyn til de mest sårbare jordtyper (sur, frit drænet sandjord) og organismer i akvatiske delmiljøer.
English: Manure from treated piglets should not be spread on vulnerable soil types, which have been identified as freely draining, acidic (pH ≤6), sandy soils.
Danish: Gylle fra behandlede grise bør ikke spredes på sårbare jordtyper, der er blevet identificeret som frit drænende, sure (pH ≤6), sandede jorder.
English: 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.
Danish: European Union Risk Assessment Report (EU RAR) on zinc (2010)http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/15064/1/lbna24587enn.pdf miljøkvalitetsstandard
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.
Danish: Endvidere ville råd om at undgå at sprede gødning på samme jordområde i flere år i træk for at sænke akkumuleringen af zink være en passende risikobegrænsningsforanstaltning.