natgillin/translations-raw huggingface dataset:
Metabolism studies have to involve crops or categories of crops in which plant protection products containing the active substance in question would be used.
V študije o presnovi morajo biti vključene kulture ali skupine kultur, na katerih bodo uporabljena fitofarmacevtska sredstva z zadevno aktivno snovjo.
If a wide range of uses in different crop categories or in the category fruits is envisaged, studies have to be carried out on at least three crops unless it can be justified that a different metabolism is unlikely to occur.
Če se predvideva široko področje uporabe v različnih skupinah kultur ali vrstah sadja, je treba izvesti študije na vsaj treh kulturah, razen če je mogoče dokazati, da drugačna presnova ni verjetna.
In cases where use is envisaged in different categories of crops, the studies must be representative for the relevant categories.
Kadar je predvidena uporaba pri različnih skupinah kultur, morajo biti študije reprezentativne za relevantne skupine.
For this purpose crops can be considered as falling into one of five categories: root vegetables, leafy crops, fruits, pulses and oilseeds, cereals.
V ta namen je mogoče razvrstiti kulture v eno od petih skupin: korenovke, listna zelenjava, sadje, zrnje stročnic in seme oljnic, žita.
If studies are available for crops from three of these categories and the results indicate that the route of degradation is similar in all three categories then it is unlikely that any more studies will be needed unless it could be expected that a different metabolism will occur.
Če so na voljo študije za tri od teh skupin in rezultati kažejo, da je pot razgradnje pri vseh treh skupinah podobna, dodatne študije niso potrebne, razen če je mogoče pričakovati, da bo presnova drugačna.
The metabolism studies have also to take into account the different properties of the active substance and the intended method of application.
Pri študijah o presnovi je treba upoštevati tudi različne lastnosti aktivne snovi ter nameravano metodo uporabe.
An evaluation of the results from different studies has to be submitted on the point and path of uptake (e.g. via leaves or roots), and on the distribution of residues between relevant parts of the crop at harvest (with particular emphasis on edible parts for man or animals).
Predložiti je treba oceno rezultatov različnih študij o mestu vstopa (npr. prek listov ali korenin) in o porazdelitvi ostankov med ustreznimi deli kultur ob spravilu (s posebnim poudarkom na delih, ki so užitni za ljudi ali živali).
If the active substance or relevant metabolites are not taken up by the crop, this must be explained.
Če kultura ne sprejme aktivno snov ali relevantnih metabolitov, je treba to razložiti.
Information on the mode of action and the physico-chemical properties of the active substance may be helpful in assessing trial data.
Pri ocenjevanju poskusnih podatkov so lahko v pomoč informacije o načinu delovanja in o fizikalno-kemičnih lastnostih aktivne snovi.
Metabolism, distribution and expression of residue in livestock
Presnova, porazdelitev in izražanje ostanka pri živini
Aim of tests
Namen testiranja
to identify the major components of the total terminal residue in edible animal products,
določiti glavne sestavine skupnih končnih ostankov v užitnih proizvodih živalskega izvora,
to quantify the rate of degradation and excretion of the total residue in certain animal products (milk or eggs) and excreta,
količinsko določiti hitrost razgradnje in izločanja skupnih ostankov pri nekaterih proizvodih živalskega izvora (mleko ali jajca) ter izločkih,
to indicate the distribution of residues between relevant edible animal products,
navesti porazdelitev ostankov med relevantnimi užitnimi proizvodi živalskega izvora,
to quantify the major components of the residue and to show the efficiency of extraction procedures for these components,
količinsko določiti glavne sestavine ostanka in prikazati učinkovitost izločanja za te sestavine,
to generate data from which a decision on the need for livestock feeding studies as provided for in point 6.4 can be made,
pridobiti podatke, na podlagi katerih je mogoče sprejeti odločitev o potrebi po študijah o krmljenju živine, kakor je določeno v točki 6.4,
Metabolism studies on animals, such as lactating ruminants (e.g. goat or cow) or laying poultry, are only required when pesticide use may lead to significant residues in livestock feed (≥ 0,1 mg/kg of the total diet as received, except special cases e.g. active substances which accumulate).
Študije o presnovi pri živalih, kot so molznice pri prežvekovalcih (npr. koze ali krave) ali nesnice pri perutnini, so obvezne le, kadar lahko uporaba pesticidov povzroči prisotnost znatnih količin ostankov v krmi (≥ 0,1 mg/kg celotnega zaužitega obroka, razen v izjemnih primerih, npr. ko se aktivne snovi kopičijo).
Where it becomes apparent that metabolic pathways differ significantly in the rat as compared to ruminants a pig study must be conducted unless the expected intake by pigs is not significant.
Kadar postane očitno, da se poti presnove pri podganah in prežvekovalcih znatno razlikujejo, je treba opraviti študijo pri prašičih, razen če pri prašičih pričakovani vnos ni znaten.
Residue trials
Poskusi ostankov
to quantify the highest likely residue levels in treated crops at harvest or outloading from store following the proposed good agricultural practice (GAP), and
količinsko določiti najvišje verjetne vrednosti ostankov v tretiranih kulturah ob spravilu ali pri razkladanju iz skladišča v skladu s predlagano dobro kmetijsko prakso (GAP) in
to determine, when appropriate, the rate of decline of plant protection product deposits.
če je ustrezno, določiti stopnjo upadanja nakopičenih ostankov fitofarmacevtskih sredstev.
These studies must always be performed where the plant protection product will be applied to plants/plant products which are used as food or feeding stuffs 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 morajo biti opravljene vedno, kadar se fitofarmacevtsko sredstvo nanaša na rastline/rastlinske proizvode, ki se uporabljajo kot živila ali krma ali kadar lahko te rastline ostanke ali druge snovi vsrkajo iz tal, razen v primerih, ko je mogoče narediti ekstrapolacijo na podlagi primernih podatkov o drugih kulturah.
Residue trial data shall be submitted in the dossier for those uses of plant protection products for which authorisation is sought at the moment of the submission of a dossier for approval of the active substance.
Podatki o poskusih ostankov so predloženi v dokumentaciji za tiste uporabe fitofarmacevtskih sredstev, za katere se zahteva registracija v trenutku, ko se dokumentacija predloži z namenom odobritve aktivne snovi.
Supervised trials shall correspond to proposed critical GAP.
Nadzorovani poskusi ustrezajo predlagani natančni dobri kmetijski praksi.
The test conditions must take into account the highest residues which may reasonably arise (e.g. maximum number of proposed applications, use of the maximum envisaged quantity, shortest pre-harvest intervals, withholding periods or storage periods) but which remain representative of the realistic worst case conditions in which the active substance would be used.
Pri pogojih testiranja je treba upoštevati najvišje količine ostankov, ki lahko v razumni meri nastanejo (npr. največje število predlaganih nanosov, uporaba najvišjega odmerka, najkrajša karenca pred spravilom, najkrajše obdobje prepovedi uporabe ali najkrajša doba shranjevanja), vendar kažejo najslabši primer pogojev, v katerih bi bila aktivna snov uporabljena.
Sufficient data must be generated and submitted to confirm that patterns determined hold for the regions and the range of conditions, likely to be encountered in the regions concerned for which its use is to be recommended.
Pripraviti in predložiti je treba zadostno količino podatkov za potrditev, da ugotovljeni vzorci veljajo za geografska območja in obseg pogojev, v katerih se bo fitofarmacevtsko sredstvo uporabljalo.
When establishing a supervised trial programme, normally factors such as climatic differences existing between production areas, differences in production methods (e.g. outdoor versus glasshouse uses), seasons of production, type of formulations, etc. shall be taken into account.
Pri določanju programa nadzorovanih poskusov se običajno upoštevajo dejavniki, kot so podnebne razlike med pridelovalnimi območji, razlike v načinih pridelave (npr. zunanja uporaba nasproti uporabi v rastlinjaku), letni časi pridelave, vrste formulacij itd.
In general, for a comparable set of conditions, trials shall be carried out over a minimum of two growing seasons.
Na splošno se za primerljivo vrsto pogojev izvedejo poskusi v najmanj dveh rastnih dobah.
All exceptions shall be fully justified.
Vse izjeme se popolnoma utemeljijo.
The precise number of trials necessary is difficult to determine in advance of a preliminary evaluation of the trial results.
Pred predhodno oceno rezultatov poskusa je težko določiti točno število potrebnih poskusov.
Minimum data requirements only apply where comparability can be established between production areas, e.g. concerning climate, methods and growing seasons of production, etc. Assuming all other variables (climate, etc.) are comparable, a minimum of eight trials representative of the proposed growing area is required for major crops.
Minimalne zahteve po podatkih veljajo le, če so pridelovalna območja primerljiva, npr. glede podnebja, načinov in rastne dobe pridelave itd. Če so domnevno vse druge spremenljivke (podnebje itd.) primerljive, je za glavne kulture treba izvesti najmanj osem poskusov, ki so reprezentativni za predlagano pridelovalno območje.
For minor crops normally four trials representative of the proposed growing area are required.
Za manj pomembne kulture so običajno potrebni najmanj štirje poskusi, reprezentativni za predlagano pridelovalno območje.
Due to the inherently higher level of homogeneity in residues arising from post-harvest treatments or protected crops, trials from one growing season will be acceptable.
Zaradi večje homogenosti pri ostankih, ki nastanejo zaradi tretiranja kultur po spravilu ali pred skladiščenjem, zadostujejo poskusi iz ene rastne dobe.
For post-harvest treatments, in principle a minimum of four trials are required, carried out preferably at different locations with different cultivars.
Za tretiranje po spravilu so načeloma potrebni najmanj štirje poskusi, ki so po možnosti opravljeni na različnih lokacijah z različnimi kultivarji.
A set of trials has to be carried out for each application method and store type unless the worst case residue situation can be clearly identified.
Za vsako metodo nanašanja in vrsto shranjevanja je treba opraviti niz poskusov, razen če je mogoče jasno določiti najslabši primer uporabe v zvezi z ostanki.
The number of studies per growing season to be performed can be reduced if it can be justified that the residue levels in plants/plant products will be lower than the limit of determination.
Število študij, ki jih je treba narediti v eni rastni dobi, se lahko zmanjša, če je mogoče dokazati, da bodo vrednosti ostankov v rastlinah/rastlinskih proizvodih nižje od meje določitve.
Where a significant part of the consumable crop 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 it can be justified that the consumable crop is not affected by the application of the plant protection product under the proposed conditions of use.
Kadar je med tretiranjem kultur pomemben del kultur primeren za uživanje, polovica navedenih nadzorovanih poskusov ostankov vključuje podatke o učinku časa na stopnjo prisotnega ostanka (študije o upadanju ostankov), razen če je mogoče dokazati, da uporaba fitofarmacevtskega sredstva pri predlaganih pogojih ne vpliva na užitne kulture.
Livestock feeding studies
Študije o krmljenju živine
The objective of these studies is to determine the residue in products of animal origin which will result from residues in feedingstuffs or fodder crops.
Cilj teh študij je določiti ostanke v proizvodih živalskega izvora, ki so posledica ostankov v krmi ali rastlinski krmi.
Feeding studies are only required:
Študije o krmljenju so obvezne le:
when significant residues (≥ 0,1 mg/kg of the total diet as received, except special cases, such as active substances which accumulate) occur in crops or part of the crop (e.g. trimmings, waste) fed to animals, and
kadar so v kulturah ali delih kultur (npr. obrezki, odpadki), s katerimi se hranijo živali, prisotne znatne količine ostankov (≥ 0,1 mg/kg celotnega zaužitega obroka, razen v izjemnih primerih, npr. ko se aktivne snovi kopičijo) in
when metabolism studies indicate that significant residues (0,01 mg/kg or above the limit of determination if this would be higher than 0,01 mg/kg) may occur in any edible animal tissue taking into account the residue levels in potential feedingstuffs obtained at the 1 × dose rate.
kadar študije presnove pokažejo, da so lahko v užitnem živalskem tkivu ob upoštevanju vrednosti ostankov v enkratnem odmerku potencialnih krmil prisotne znatne količine ostankov (0,01 mg/kg ali nad mejo določitve, če je višja od 0,01 mg/kg).
Where appropriate separate feeding studies for lactating ruminant and/or laying poultry shall be submitted.
Kadar je ustrezno, se predložijo ločene študije za molznice pri prežvekovalcih in/ali nesnice pri perutnini.
Where it appears from the metabolism studies submitted in accordance with point 6.2 that metabolic pathways differ significantly in the pig as compared to ruminants, a pig feeding study must be conducted unless the expected intake by pigs is not significant.
Kadar je iz študij o presnovi, predloženih v skladu s točko 6.2, razvidno, da se poti presnove pri prašičih v primerjavi s prežvekovalci znatno razlikujejo, je treba izvesti študijo o krmljenju prašičev, razen če pričakovani vnos pri prašičih ni znaten.
In general, the feed is administered in three dosages (expected residue level, three to five times, and 10 times the expected residue level).
Na splošno se krma daje v treh odmerkih (pričakovana vrednost ostankov, tri- do petkratna in 10-kratna pričakovana vrednost ostankov).
When setting the 1 × dose, a theoretical feed ration must be compiled.
Pri določanju enkratnega odmerka je treba sestaviti teoretični obrok hrane.
Effects of industrial processing and/or household preparations
Učinki industrijske predelave in/ali priprave v gospodinjstvu
The decision as to whether it is necessary to carry out processing studies will depend on:
Odločitev o tem, ali je treba izvesti študije o predelavi, je odvisna od:
the importance of a processed product in the human or animal diet,
pomembnosti predelanega proizvoda za prehrano ljudi ali živali,
the level of residue in the plant or plant product to be processed,
vrednosti ostankov v rastlini ali rastlinskem proizvodu, ki naj bi bil predelan,
the physico-chemical properties of the active substance or relevant metabolites, and
fizikalno-kemičnih lastnosti aktivne snovi ali relevantnih metabolitov in
the possibility that degradation products of toxicological significance may be found after processing of the plant or plant product.
možnosti, da bo po predelavi rastline ali rastlinskega proizvoda mogoče najti razgradne produkte toksikološkega pomena.
Processing studies are not normally necessary if no significant or no analytically determinable residues occur in the plant or plant product which would be processed, or if the total theoretical maximum daily intake (TMDI) is less than 10 % of the ADI.
Študije o predelavi običajno niso obvezne, če v rastlini ali rastlinskem proizvodu, namenjenem za predelavo, niso prisotni nobeni pomembni ali analitično določljivi ostanki ali če je največji skupni teoretični dnevni vnos nižji od 10 % povprečnega dnevnega vnosa.
In addition, processing studies are not normally required for plants or plant products mostly eaten raw except for those with inedible portions such as citrus, banana or kiwi fruit where data on the distribution of the residue in peel/pulp may be required.
Poleg tega študije o predelavi običajno niso obvezne za rastline ali rastlinske proizvode, ki se v glavnem uživajo surovi, razen tistih z neužitnimi deli, kot so citrusi, banana ali kivi, kjer so lahko potrebni podatki o porazdelitvi ostankov v lupini/mesu sadežev.
‘Significant residues’ generally refer to residues above 0,1 mg/kg.
„Pomembni ostanki“ se v glavnem nanašajo na ostanke nad 0,1 mg/kg.
If the pesticide concerned has a high acute toxicity and/or a low ADI, consideration must be given to conducting processing studies for determinable residues below 0,1 mg/kg.
Če ima zadevni pesticid visoko akutno toksičnost in/ali nizek ADI, je treba upoštevati izvajanje študij o predelavi za določljive ostanke pod 0,1 mg/kg.
Studies on the effects on the nature of the residue are not normally required where only simple physical operations, not involving a change in temperature of the plant or the plant product, are involved such as washing, trimming or pressing.
Študije o učinkih predelave na naravo ostankov običajno niso potrebne, kadar gre le za preproste fizične postopke, ki ne vključujejo spremembe temperature rastline ali rastlinskega proizvoda, kot so pranje, rezanje ali stiskanje.
Effects on the nature of the residue
Učinki na naravo ostanka
The objective of these studies is to establish whether or not breakdown or reaction products arise from residues in the raw products during processing which may require a separate risk assessment.
Namen teh študij je ugotoviti, ali med predelavo iz ostankov v surovih proizvodih nastajajo razgradni ali reakcijski produkti, ki bi zahtevali ločeno oceno tveganja.
Depending upon the level and chemical nature of the residue in the raw commodity, a set of representative hydrolysis situations (simulating the relevant processing operations) shall be investigated, where appropriate.
Glede na vrednosti in kemijsko obliko ostankov v surovini se po potrebi preuči niz reprezentativnih hidroliznih situacij (ki simulirajo relevantne predelovalne postopke).
The effects of process other than hydrolysis may also have to be investigated, where the properties of the active substance or metabolites indicate that toxicologically significant degradation products may occur as a result of these processes.
Poleg hidrolize je treba raziskati tudi druge učinke predelave, kadar lastnosti aktivne snovi ali metabolitov kažejo, da zaradi teh postopkov lahko nastanejo toksikološko pomembni razgradni produkti.
The studies are normally conducted with a radio-labelled form of the active substance.
Te študije se običajno izvajajo z obliko aktivne snovi, označeno z radioaktivnimi markerji.
Effects on the residue levels
Učinki na vrednost ostanka
The main objectives of these studies are:
Glavni cilji teh študij so:
to determine the quantitative distribution of residues in the various intermediate and end products, and to estimate transfer factors,
določiti količinsko porazdelitev (prenos) ostankov v različnih vmesnih in končnih proizvodih ter oceniti dejavnike prenosa,
to enable a more realistic estimate to be made of dietary intake of residues.
omogočiti bolj realistično oceno vnosa ostankov s prehrano.
Processing studies shall represent household processing and/or actual industrial processes.
Študije o predelavi predstavljajo pripravo v gospodinjstvu in/ali dejansko industrijsko predelavo.
In the first instance it is usually only necessary to carry out a core set of ‘balance studies’ representative of the common processes relevant to the plants or plant products containing significant residues.
Najprej je običajno treba izvesti le niz osnovnih „študij o ravnovesju“, reprezentativnih za skupne postopke pri rastlinah ali rastlinskih proizvodih, ki vsebujejo znatne količine ostankov.
Justification shall be given for the selection made of these representative process(es).
Izbira teh reprezentativnih postopkov se utemelji.
The technology to be used in processing studies shall always correspond as closely as possible to the actual conditions that are normally used in practice.
Tehnologija, uporabljena pri študijah o predelavi, vedno čim bolj ustreza dejanskim pogojem v praksi.
A balance sheet shall be made in which the mass balance of residues in all intermediate and end products is investigated.
Pripravi se razpredelnica, v kateri se pojasni ravnovesje mase ostankov v vseh vmesnih in končnih proizvodih.
In drawing up such a balance sheet any concentrations or reductions in residues in individual products can be recognised and the corresponding transfer factors can also be determined.
Pri pripravi take razpredelnice je mogoče prepoznati vse koncentracije ali znižanja ostankov v posameznih proizvodih in tudi določiti ustrezne faktorje prenosa.
If the processed plant products play an important part in the diet, and if the ‘balance study’ indicates that a significant transfer of residue into the processed products could occur, then three ‘follow-up studies’ to determine residue concentration or dilution factors must be carried out.
Če predelani rastlinski proizvodi pomenijo pomemben del prehrane in če „študija o ravnovesju“ pokaže, da bi lahko prišlo do znatnega prenosa ostankov v predelane proizvode, je treba izvesti tri „nadaljnje študije“ za določitev koncentracije ostankov ali dejavnikov razredčenja.
Residues in succeeding crops
Ostanki v naslednjih kulturah
The objective of these studies is to permit an evaluation of possible residues in succeeding crops.
Cilj teh študij je omogočiti oceno možnih ostankov v naslednjih kulturah.
Where data generated in accordance with point 7.1 of this Annex or point 9.1 of the Annex to Regulation (EU) No 545/2011, shows that significant residues (> 10 % of the applied active substance as a total of unchanged active substance and its relevant metabolites or degradation products) remain in soil or in plant materials, such as straw or organic material up to sowing or planting time of possible succeeding crops, and which could lead to residues above the limit of determination in succeeding crops at harvest, consideration shall be given to the residue situation.
Kadar podatki, pridobljeni v skladu s točko 7.1 te priloge ali točko 9.1 Priloge k Uredbi (EU) št. 545/2011, kažejo, da v tleh ali rastlinskih materialih, kot je slama ali organski material, do setve ali sejanja morebitnih nadaljnjih kultur ostanejo znatne količine ostankov (> 10 % nanesene aktivne snovi celotne nespremenjene aktivne snovi in njenih relevantnih metabolitov ali razgradnih produktov), ki bi lahko presegale mejo določitve pri naslednjih kulturah pri spravilu, se ti ostanki upoštevajo.
This shall include consideration of the nature of the residue in the succeeding crops and involve at least a theoretical estimation of the level of these residues.
Pri tem se upošteva narava ostanka v naslednjih kulturah in, vsaj teoretično, ocena vrednosti teh ostankov.
If the likelihood of residues in succeeding crops can not be excluded, metabolism and distribution studies shall be carried out, if necessary followed by field trials.
Če ni mogoče izključiti verjetnosti ostankov v naslednjih kulturah, je treba izvesti študije o presnovi in porazdelitvi in po potrebi še poskuse na prostem.
If a theoretical estimation of residues in succeeding crops is done, full details and a justification shall be given.
Če je opravljena teoretična ocena ostankov v naslednjih kulturah, se predložijo vse podrobne informacije in utemeljitev.
Metabolism and distribution studies and field trials, if necessary, shall be carried out on representative crops chosen to represent normal agricultural practice.
Študije o presnovi in porazdelitvi ter poskusi na prostem, če so potrebni, se opravijo na reprezentativnih kulturah, ki so izbrane tako, da predstavljajo običajno kmetijsko prakso.
Proposed maximum residue levels (MRLs) and residue definition
Predlagane mejne vrednosti ostankov (MRL) ter opredelitev ostanka