natgillin/translations-raw huggingface dataset:
Metabolism studies on fish may be required where the plant protection product is used in crops whose parts or products, also after processing, are fed to fish and where residues in feed may occur from the intended applications.
Študije o presnovi na ribah so lahko potrebne, kadar se fitofarmacevtsko sredstvo uporabi na kulturah, katerih deli ali proizvodi, tudi po predelavi, se uporabljajo za krmo rib, in kadar se lahko zaradi predvidenega nanosa pojavijo ostanki v krmi.
Results from studies provided for under point 8.2.2.3 may be used if it can be demonstrated with scientific evidence that the results of these studies may be assumed to be equivalent.
Rezultati študij iz točke 8.2.2.3 se lahko uporabijo, če je mogoče znanstveno dokazati, da se lahko rezultati teh študij štejejo za enake.
Special consideration shall be given to the different routes of ingestion.
Posebna pozornost se nameni različnim načinom zaužitja.
The objectives of magnitude of residue trials in plants shall be the following:
Cilji poskusov za določitev ostankov pri rastlinah so:
to quantify the highest likely residue levels of all components of the different residue definitions in treated crops, at harvest or outloading from store, in accordance with the proposed GAP, and
količinsko določiti najvišje verjetne vrednosti ostankov vseh sestavin iz različnih opredelitev ostankov v tretiranih kulturah ob spravilu ali pri razkladanju iz skladišča v skladu s predlagano dobro kmetijsko prakso (DKP) in,
to determine, where appropriate, the decline rate of plant protection product residues in plants.
kadar je primerno, določiti stopnjo upadanja ostankov fitofarmacevtskih sredstev v rastlinah.
These studies shall always be performed where the plant protection product is to be applied to plants or plant products that are used as food or feed or where residues from soil or other substrates can be taken up by such plants except where extrapolation from adequate data on another crop is possible.
Te študije se izvedejo vedno, kadar se fitofarmacevtska sredstva nanašajo na rastline ali rastlinske proizvode, ki se uporabljajo kot hrana ali krma, ali kadar lahko te rastline vsrkajo ostanke iz zemlje ali drugih substratov, razen kadar je možna ekstrapolacija iz primernih podatkov o drugi kulturi.
When planning residue trials, it shall be borne in mind that information on the residues in ripe or unripe crops may be of interest with respect to the risk assessment in other areas like ecotoxicology or worker safety.
Pri načrtovanju poskusov za določitev ostankov se upošteva, da so lahko informacije o ostankih v zrelih ali nezrelih kulturah pomembne za oceno tveganja na drugih področjih, kot je ekotoksikologija ali varnost pri delu.
Supervised residue trials shall correspond to the proposed critical GAP.
Nadzorovani poskusi za določitev ostankov ustrezajo predlagani natančni dobri kmetijski praksi.
The test conditions (such as maximum number of proposed applications, shortest interval between applications, maximum application rate and concentration, most critical safety intervals [13] with regard to exposure) shall be defined to identify the highest residues which may reasonably arise and shall be representative of the realistic conditions at the critical GAP in which the active substance is to be used.
Preskusni pogoji (kot so največje število predlaganih nanosov, najkrajše obdobje med nanosi, največji odmerek in koncentracija nanosa, najpomembnejše karenčne dobe [13] glede izpostavljenosti) se opredelijo za določitev najvišje količine ostankov, ki lahko v razumni meri nastanejo, pri čemer se upoštevajo dejanski pogoji pri natančni DKP, v katerih se bo aktivna snov uporabila.
When establishing a supervised residue trial programme, factors such as main growing areas and the range of conditions, likely to be encountered in the main growing areas concerned shall be considered.
Pri pripravi programa nadzorovanih poskusov o določitvi ostankov se upoštevajo dejavniki, kot so glavna pridelovalna območja in sklop verjetnih pogojev na zadevnih glavnih pridelovalnih območjih.
Differences in agricultural production methods (for example outdoor versus indoor uses), seasons of production and types of formulations shall be taken into account.
Upoštevajo se razlike v načinih kmetijske pridelave (na primer zunanja uporaba v primerjavi z notranjo uporabo), letnih časih pridelave in vrstah formulacij.
For the evaluation of residue behaviour and the setting of maximum residue levels (MRLs) according to Regulation (EC) No 396/2005, the Union shall be divided into two zones, a Northern European and a Southern European zone.
Za oceno obnašanja ostankov in določitev mejnih vrednosti ostankov (MRL) v skladu z Uredbo (ES) št. 396/2005 se Unija razdeli na dve coni, in sicer severnoevropsko cono in južnoevropsko cono.
For the purpose of use in greenhouses, as post-harvest treatment and for treatment of empty storage rooms, one residue zone shall apply.
Za namene uporabe v rastlinjakih, za tretiranje po spravilu in za tretiranje praznih skladišč se uporablja ena cona ostankov.
The number of trials necessary is difficult to determine before the evaluation of their results.
Število potrebnih poskusov je težko določiti pred oceno njihovih rezultatov.
Assuming all other variables having an impact on the residue levels are comparable, the minimum number of trials shall vary for each residue zone between a minimum of 4 trials for a minor crop and a minimum of 8 trials for a major crop.
Če so domnevno vse druge spremenljivke, ki vplivajo na vsebnost ostankov, primerljive, se najmanjše število poskusov razlikuje glede na posamezno cono ostankov, pri čemer so za manj pomembne kulture potrebni vsaj štirje poskusi, za glavne kulture pa vsaj osem poskusov.
However, if the GAP is the same in both residue zones, 6 trials equally distributed in the representative growing zones are normally sufficient for a minor crop.
Če je DKP enaka v obeh conah ostankov, je za manj pomembne kulture običajno dovolj šest poskusov, ki so enakomerno porazdeljeni v reprezentativnih conah pridelave.
The number of studies to be performed may be reduced if residue trials show that the residue levels in plants or plant products are lower than the LOQ.
Število študij, ki jih je treba izvesti, je lahko manjše, če je s poskusi za določitev ostankov ugotovljeno, da je vsebnost ostankov v rastlinah ali rastlinskih proizvodih nižja od LOQ.
The number of trials shall not be below the minimum of three per zone for minor crops and four per zone for major crops.
Za manj pomembne kulture se opravijo vsaj trije poskusi na cono, za glavne kulture pa štirje poskusi.
In cases were a ‘zero’ residue situation is predicted from representative plant metabolism studies, three trials shall be performed for commodities significant in diet.
Kadar so na podlagi reprezentativnih študij o presnovi rastlin predvideni „ničelni“ ostanki, se za prehransko pomembne proizvode opravijo trije poskusi.
No trials shall be required for commodities insignificant in diet.
Za prehransko nepomembne proizvode poskusi niso potrebni.
A ‘zero’ residue situation shall be predicted where no detectable residues occur in studies with exaggerated application rates compared to the envisaged ones.
„Ničelni“ ostanki se predvidijo, kadar v študijah s povečanimi odmerki v primerjavi s predvidenimi odmerki niso ugotovljeni ostanki, ki jih je mogoče zaznati.
Provided that conditions are comparable and that trials are widely spread over different zones, it shall be sufficient to carry out trials over one growing season.
Če so pogoji primerljivi in poskusi razširjeni v različnih conah, zadostujejo poskusi, izvedeni v eni rastni dobi.
Part of the trials may be replaced by trials performed outside the Union, provided that they correspond to the critical GAP and that the production conditions (such as cultural practices, climatic conditions) are comparable.
Del poskusov se lahko nadomesti s poskusi, ki se opravijo zunaj Unije, če ustrezajo natančni DKP in če so pogoji pridelave (kot so prakse pridelave in podnebni pogoji) primerljivi.
Trials showing the residue behaviour in post-harvest treatments shall be carried out at different locations with different cultivars.
Poskusi o obnašanju ostankov pri tretiranjih po spravilu se izvedejo na različnih lokacijah z različnimi kultivarji.
A set of trials shall be carried out for each application method and storage condition, unless the worst case residue situation can be clearly identified.
Za vsako metodo nanašanja in pogoj skladiščenja se opravi sklop poskusov, razen če je mogoče jasno določiti najslabši primer uporabe v zvezi z ostanki.
Where a plant protection product has both a field use and an indoor use with the same GAP, a full data package shall be submitted for both situations, unless it is already accepted that one use is the critical GAP.
Kadar se fitofarmacevtsko sredstvo uporablja na prostem in v zaprtih prostorih v skladu z isto DKP, se za oba primera predložijo popolni podatki, razen če je že sprejeto, da je ena uporaba natančna DKP.
It shall be checked on a case-by-case basis, taking into account plant morphology and application conditions, whether extrapolation from the crop used for the metabolism study to other crops belonging to the same crop group is possible.
Za vsak primer posebej se ob upoštevanju morfologije rastline in pogojev nanosa preveri, ali je možna ekstrapolacija s kulture, ki je bila uporabljena v študiji o presnovi, na druge kulture, ki spadajo v isto skupino kultur.
Where a significant part of the consumable commodity is present at the time of application, half of the supervised residue trials reported shall include data to show the effect of time on the level of residue present (residue decline studies), unless the consumable part is not exposed during application of the plant protection product under the proposed conditions of use.
Kadar je med nanosom prisoten pomemben del užitnega proizvoda, polovica navedenih nadzorovanih poskusov za določitev ostankov vključuje podatke o učinku časa na količino prisotnega ostanka (študije o upadanju ostankov), razen če užitni del med nanosom fitofarmacevtskega sredstva pri predlaganih pogojih uporabe ni izpostavljen.
For crops harvested after blossom (such as fruits or fruiting vegetables) a significant part of the consumable crop is present from full blossom (BBCH 65) onwards.
Pri kulturah, ki se spravijo po cvetenju (kot je sadje ali plodovke), je pomemben užitni del kulture prisoten od polnega cveta (BBCH 65).
In case of most crops from which leafy parts are harvested (for example lettuce), this condition is satisfied if 6 true leaves, leaf pairs or whorls are unfolded (BBCH 16).
Pri večini kultur, pri katerih se spravijo listni deli (na primer zelena solata), je ta pogoj izpolnjen, če je razprtih šest pravih listov, parov listov ali vencev (BBCH 16).
In case of an active substance for which an ARfD has been derived, the distribution of residues among single units may be investigated through variability studies.
V primeru aktivne snovi, za katero je določen ARfD, se lahko porazdelitev ostankov med posamezne enote preuči s študijami variabilnosti.
If a sufficient number of results is available, the default variability factor may be replaced by a specific factor derived from these studies.
Če je na voljo dovolj rezultatov, se lahko privzeti faktor variabilnosti nadomesti s posebnim faktorjem, določenim na podlagi teh študij.
The objective of feeding studies shall be to determine residues in products of animal origin which result from residues in feed.
Cilj študij o krmljenju je določiti ostanke v proizvodih živalskega izvora, ki so posledica ostankov v krmi.
The results from a feeding study conducted with laying hens shall be extrapolated to all food producing poultry.
Rezultati študije o krmljenju, ki je bila izvedena na kokoših nesnicah, se ekstrapolirajo na vso perutnino za proizvodnjo hrane.
The results from a feeding study with lactating cows and, where necessary, with pigs shall be extrapolated to all food producing mammals.
Rezultati študije o krmljenju, ki je bila izvedena na kravah mlekaricah in po potrebi prašičih, se ekstrapolirajo na vse sesalce za proizvodnjo hrane.
Feeding studies shall be provided where metabolism studies indicate that residues at levels of above 0,01 mg/kg may occur in edible animal tissue, milk, eggs or fish, taking into account the residue levels in potential feeding stuffs, obtained at the 1 × dose rate, calculated on the dry weight basis.
Študije o krmljenju se zagotovijo, kadar študije o presnovi kažejo, da je lahko v užitnem živalskem tkivu, mleku, jajcih ali ribah več kot 0,01 mg/kg ostankov, pri čemer se upoštevajo količine ostankov v možni krmi, pridobljene pri enkratnem odmerku in izračunane na podlagi suhe teže.
Feeding studies shall not be required where intake is below 0,004 mg/kg bw/day, except in cases where the residue, that is to say the active substance, its metabolites or breakdown products, as defined in the residue definition for risk assessment, tends to accumulate.
Študije o krmljenju niso potrebne, kadar je vnos manjši od 0,004 mg/kg telesne teže/dan, razen če se ostanek, tj. aktivna snov, njeni metaboliti ali razgradni produkti (iz opredelitve ostankov za oceno tveganja), kopiči.
Poultry feeding studies shall be carried out in laying hens.
Študije o krmljenju perutnine se izvedejo na kokoših nesnicah.
For each treatment regime chosen a minimum of nine chickens should be treated.
Za vsako izbrano tretiranje je treba obravnavati vsaj devet kokoši.
In general, the feed shall be administered in three dosages (first dose = expected residue level).
Na splošno se krma daje v treh odmerkih (prvi odmerek = pričakovana vrednost ostankov).
The animals shall be dosed for a minimum of 28 days or until plateau level is reached in eggs.
Živalim se odmerki dajejo najmanj 28 dni ali dokler v jajcih ni dosežena najvišja raven.
Ruminant feeding studies shall be carried out in lactating cows.
Študije o krmljenju prežvekovalcev se izvedejo na kravah mlekaricah.
For each treatment regime chosen, a minimum of three dairy cows shall be treated.
Za vsako izbrano tretiranje se obravnavajo vsaj tri krave mlekarice.
The animals shall be dosed for a minimum of 28 days or until plateau level is reached in milk.
Živalim se odmerki dajejo najmanj 28 dni ali dokler v mleku ni dosežena najvišja raven.
Where it appears from the metabolism studies that metabolic pathways differ significantly in pigs as compared to ruminants, a pig feeding study may be conducted.
Kadar se na podlagi študij o presnovi zdi, da se presnovne poti pri prašičih pomembno razlikujejo od presnovnih poti pri prežvekovalcih, se lahko izvede študija o krmljenju prašičev.
For each treatment regime chosen a minimum of three pigs shall be treated.
Za vsako izbrano tretiranje se obravnavajo vsaj trije prašiči.
The animals shall be dosed for at least the same time as ruminants.
Živalim se odmerki dajejo vsaj toliko časa kot prežvekovalcem.
A fish feeding study may be required where residues at levels above 0,01 mg/kg may be reasonably expected in edible tissues, based on the findings of the fish metabolism study and the estimated maximum residues which might occur in fish feed.
Študija o krmljenju rib je lahko potrebna, kadar se lahko na podlagi ugotovitev študij o presnovi rib in ocenjene največje količine ostankov v krmi za ribe v užitnem tkivu upravičeno pričakuje več kot 0,01 mg/kg ostankov.
Particular attention should be laid on lipophilic substances with an intrinsic tendency for accumulation.
Posebno pozornost je treba nameniti lipofilnim snovem, ki se pogosto kopičijo.
The objective of studies on the nature of the residue shall be to establish whether or not breakdown or reaction products arise from residues in the raw agricultural commodity during processing, which may require a separate risk assessment.
Namen študij o vrsti ostanka je ugotoviti, ali med predelavo kmetijske surovine iz ostankov nastajajo razgradni ali reakcijski produkti, zaradi katerih bo morda potrebna ločena ocena tveganja.
Studies on the nature of residues in processing shall be provided where residues in products of plant or animal origin subject to processing may occur at a level of or higher than 0,01 mg/kg (based on the residue definition for risk assessment for the raw commodity).
Študije o vrsti ostankov pri predelavi se zagotovijo, kadar se lahko v proizvodih rastlinskega ali živalskega izvora, ki se predelujejo, pojavi najmanj 0,01 mg/kg ostankov (na podlagi opredelitve ostankov za oceno tveganja v zvezi s surovino).
No studies shall, however, be required in the following cases:
Študije niso potrebne v naslednjih primerih:
substances with a water solubility < 0,01 mg/L;
za snovi s topnostjo v vodi < 0,01 mg/l,
only simple physical operations, not involving a change in temperature of the commodity are carried out, such as washing, trimming or pressing; or
kadar se izvedejo le preprosti fizikalni postopki, ki ne vključujejo spremembe temperature proizvoda, kot je pranje, rezanje ali stiskanje, ali
the distribution of residues between pulp and inedible peel is the only effect of processing.
kadar je porazdelitev ostankov med mesom in neužitno lupino edini učinek predelave.
Depending upon the expected level and chemical nature of the residue in the product of plant or animal origin, a set of representative hydrolysis situations simulating the relevant processing operations shall be investigated, where appropriate.
Glede na pričakovano vrednost in kemijsko obliko ostankov v proizvodu rastlinskega ali živalskega proizvoda se po potrebi preuči sklop reprezentativnih hidroliznih situacij, ki simulirajo ustrezne predelovalne postopke.
Consideration shall also be given to the effects of processes other than hydrolysis and the potential for the formation of toxicologically significant breakdown products.
Poleg hidrolize se obravnavajo tudi drugi učinki predelave in možnost za nastanek toksikološko pomembnih razgradnih produktov.
The studies shall be conducted with one or more radio-labelled forms of the relevant substance.
Študije se izvedejo z eno ali več oblikami zadevne snovi, označene z radioaktivnimi markerji.
The objectives of studies concerning distribution of the residue in inedible peel and pulp shall be:
Cilji študij o porazdelitvi ostankov v neužitni lupini in mesu so:
to determine the quantitative distribution of residues between inedible peel and pulp,
določiti količinsko porazdelitev ostankov med neužitno lupino in mesom,
to estimate peeling factors, and
oceniti dejavnike lupljenja in
to allow a more realistic estimation of dietary intake of residues.
omogočiti bolj realistično oceno vnosa ostankov s prehrano.
These studies shall be provided for plant products where the peel is either inedible (such as melons, bananas) or is very rarely entirely eaten by consumers (such as citrus fruit).
Te študije se zagotovijo za rastlinske proizvode, pri katerih je lupina neužitna (kot so melone in banane) ali jih potrošniki zelo redko pojejo v celoti (kot so citrusi).
These studies shall be performed as part of supervised residue trials, the number of results reported depending on the number of residue trials conducted.
Te študije se izvedejo v okviru nadzorovanih poskusov za določitev ostankov, pri čemer je število navedenih rezultatov odvisno od števila izvedenih poskusov za določitev ostankov.
Special attention shall be paid to possible contamination of the pulp.
Posebna pozornost se nameni možni kontaminaciji mesa.
Precautionary measures shall be taken in order to quantify a realistic highest residue level.
Za količinsko določitev dejanske najvišje vrednosti ostankov se sprejmejo previdnostni ukrepi.
The main objectives of studies concerning magnitude of residues in processed commodities shall be:
Glavni cilji študij o količini ostankov v predelanih proizvodih so:
to determine the quantitative distribution of residues in the various processed commodities used as food or feed,
določiti količinsko porazdelitev ostankov v različnih predelanih proizvodih, ki se uporabljajo kot hrana ali krma,
to estimate processing factors, and
oceniti dejavnike predelave in
The following points shall be taken into consideration when deciding whether it is necessary to carry out processing studies:
Pri odločanju o potrebi po izvedbi študij o predelavi se upoštevajo naslednje točke:
the dietary burden of a processed product in the human (such as apples) or animal diet (such as apple pomace);
prehranska obremenitev predelanega proizvoda za prehrano ljudi (kot so jabolka) ali živali (kot so jabolčne tropine);
the level of residue in the plant or plant product to be processed (normally ≥ 0,1 mg/kg);
vrednosti ostankov v rastlini ali rastlinskem proizvodu, ki se bo predelal (običajno ≥ 0,1 mg/kg);
the possibility that breakdown products of toxicological significance may occur after processing of the plant or plant product.
možnost, da bodo po predelavi rastline ali rastlinskega proizvoda nastali razgradni produkti toksikološkega pomena.
If the level of residues is less than 0,1 mg/kg, processing studies shall be carried out if the contribution of the commodity under consideration to the theoretical maximum daily intake (TMDI) is ≥ 10 % of the ADI or if the estimated daily intake is ≥ 10 % of the ARfD for any European consumer group diet.
Če je ostankov manj kot 0,1 mg/kg, se študije o predelavi izvedejo, če je prispevek obravnavanega proizvoda k največjemu teoretičnemu dnevnemu vnosu višji ali enak 10 % ADI ali če je ocenjen dnevni vnos višji ali enak 10 % ARfD za prehrano katere koli skupine evropskih potrošnikov.
Processing studies shall not be required if plants or plant products are exclusively used raw (unprocessed) for food and feed purposes.
Študije o predelavi niso potrebne, če se rastline ali rastlinski proizvodi za prehrano in krmljenje uporabljajo izključno surovi (nepredelani).
In some cases, a simple calculation shall be sufficient to determine the processing factor such as concentration from dehydration or dilution factors, as long as the process under consideration is not expected to have an influence on the nature of residues.
V nekaterih primerih je za določitev dejavnika predelave, kot je koncentracija zaradi dejavnikov dehidracije ali redčenja, dovolj enostaven izračun, če obravnavani postopek predvidoma ne vpliva na vrsto ostankov.
Industrial processing
Industrijska predelava
If the properties of the active substance, the impurity or the metabolite, as appropriate, indicate that it might concentrate in a given processed fraction, then a processing study shall be necessary even in situations where the residue in the plant or plant product to be processed is lower than 0,1 mg/kg.
Če lastnosti aktivne snovi, nečistoče ali metabolita, kakor je primerno, kažejo, da bi se lahko kopičila v zadevnem delu predelave, je študija o predelavi potrebna, tudi če je ostanek v rastlini ali rastlinskem proizvodu, ki bo predelan, manjši od 0,1 mg/kg.
In such cases, exaggerated application rates up to 5 × or shortened PHIs shall be applied where necessary to achieve a quantifiable residue in the plant or plant product to be processed.
V takšnih primerih se po potrebi uporabijo največ petkratni povečani odmerki ali krajša karenca pred spravilom, da se dosežejo količinsko določljivi ostanki v rastlini ali rastlinskem proizvodu, ki bo predelan.
A processing study shall not be required if exaggerated application rates (up to 5 ×) fail to yield a quantifiable residue in the plant or plant product to be processed.
Študija o presnovi ni potrebna, če pri povečanih odmerkih (največ petkratnih) niso ugotovljeni količinsko določljivi ostanki v rastlini ali rastlinskem proizvodu, ki bo predelan.
Phytotoxicity shall be considered when contemplating exaggerated rate treatments.
Fitotoksičnost se obravnava hkrati z obravnavanjem tretiranja s povečanimi odmerki.
Domestic processing
Domača predelava