natgillin/translations-raw huggingface dataset:
Viable residue A residue that is capable of replication or of transferring genetic material.
Aktivni ostanek ostanek, ki se je zmožen razmnoževati ali je zmožen prenašati genski material.
Viroid Any of a class of infectious agents consisting of a small strand of RNA not associated with any protein.
Viroid kateri koli iz razreda povzročiteljev okužb s kratko enojnovijačno RNK, ki ni povezana z nobeno beljakovino.
The RNA does not code for proteins and is not translated; it is replicated by host cell enzymes.
RNK ne kodira beljakovin in ni prevedena; množi se s celičnimi encimi gostitelja.
Virulence Measurement of the degree of disease producing ability of a micro-organism as indicated by the severity of the disease produced.
Virulenca stopnja zmožnosti mikroorganizma povzročiti bolezen, ki se izraža z resnostjo povzročene bolezni.
Measure of the dosage (inoculum size) required to cause a specific degree of pathogenicity.
Merska enota potrebnega odmerka (velikost cepiva), ki povzroči neko stopnjo patogenosti.
It is measured experimentally by the median lethal dose (LD50) or median infective dose (ID50).
Meri se poskusno s srednjo vrednostjo letalnega odmerka (LD50) ali srednjo vrednostjo infektivnega odmerka (ID50).
The objective of an evaluation is to identify and assess, on a scientific basis and until further experience is reached on a case-by-case basis, potential adverse effects on human and animal health and the environment of the use of a microbial plant protection product.
Cilj ocenjevanja je, da se na znanstveni podlagi, in dokler se ne pridobijo dodatne izkušnje, na podlagi posamičnih primerov določijo in ocenijo možni škodljivi učinki na zdravje ljudi in živali ter na okolje zaradi uporabe mikrobiološkega fitofarmacevtskega sredstva.
The evaluation shall also be carried out in order to identify the need for risk management measures and to identify and recommend suitable measures.
Z ocenjevanjem se opredeli tudi potreba po ukrepih za obvladovanje tveganja ter se določijo in priporočijo ustrezni ukrepi.
Due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and micro-organisms used as plant protection products.
Zaradi zmožnosti mikroorganizmov, da se razmnožujejo, je jasna razlika med kemikalijami in mikroorganizmi, ki se uporabljajo kot fitofarmacevtska sredstva.
Hazards arising are not necessarily of the same nature as those presented by chemicals, especially in relation to the capacity of micro-organisms to persist and multiply in different environments.
Nevarnosti zaradi tega niso nujno iste narave kot nevarnosti pri kemikalijah, zlasti glede na zmožnost mikroorganizmov, da obstanejo in se množijo v različnih okoljih.
Moreover, micro-organisms consist of a wide range of different organisms, all with their own unique characteristics.
Mikroorganizme sestavljajo številni različni organizmi in vsi imajo enkratne značilnosti.
These differences between micro-organisms must be taken into account in the evaluation.
Pri ocenjevanju je treba upoštevati te razlike med mikroorganizmi.
The micro-organism in the plant protection product should ideally function as a cell factory working directly on the spot where the target organism is harmful.
Mikroorganizem v fitofarmacevtskem sredstvu mora v idealnih razmerah delovati kot tovarna celic, ki deluje neposredno tam, kjer je ciljni organizem škodljiv.
Thus understanding the mode of action is a crucial step in the evaluation process.
Zato je razumevanje načina delovanja ključen korak v postopku ocenjevanja.
Micro-organisms may produce a range of different metabolites (e.g. bacterial toxins or mycotoxins) many of which may have toxicological significance, and one or more of which may be involved in the mode of action of the plant protection product.
Mikroorganizmi lahko proizvajajo številne različne metabolite (npr. bakterijske toksine ali mikotoksine), od katerih so številni toksikološko pomembni, eden ali več pa jih je lahko vključenih v način delovanja fitofarmacevtskega sredstva.
The characterisation and identification of relevant metabolites must be assessed and the toxicity of these metabolites must be addressed.
Opredeliti je treba značilnosti in imena relevantnih metabolitov ter obravnavati njihovo toksičnost.
Information on production and/or relevance of metabolites may be deduced from:
Informacije o produkciji in/ali pomembnosti metabolitov se lahko povzamejo iz:
toxicity studies;
študij o toksičnosti;
biological properties of the micro-organism;
bioloških lastnosti mikroorganizma;
relationship to known plant, animal or human pathogens;
odnosa do znanih rastlinskih, živalskih ali človeških patogenov;
mode of action;
načina delovanja;
On the basis of this information, metabolites may be considered as possibly being relevant.
Na podlagi navedenih informacij se metaboliti lahko štejejo za morebitno pomembne.
Therefore potential exposure to these metabolites must be assessed, in order to decide on their relevance.
Pri odločitvi, kako pomembni so, je treba oceniti možno izpostavljenost tem metabolitom.
Having regard to current scientific and technical knowledge, Member States shall evaluate the information provided in accordance with the requirements of part B of the Annex to Regulation (EU) No 544/2011 and part B of the Annex to Regulation (EU) No 545/2011 and in particular:
Države članice ob upoštevanju trenutnih znanstvenih in tehničnih dognanj ocenijo informacije, predložene v skladu z zahtevami iz dela B Priloge k Uredbi (EU) št. 544/2011 in dela B Priloge k Uredbi (EU) št. 545/2011, ter zlasti:
identify the hazards arising, assess their significance and make a judgement as to the likely risks to humans, animals or the environment; and
opredelijo nevarnosti pri fitofarmacevtskem sredstvu, ocenijo pomembnost teh nevarnosti in presodijo verjetno tveganje za ljudi, živali ali okolje ter
assess the performance in terms of efficacy and phytotoxicity/pathogenicity of the plant protection product for each use for which authorisation is sought.
ocenijo delovanje glede učinkovitosti in fitotoksičnosti/patogenosti fitofarmacevtskega sredstva za vsak posamezen način uporabe, za katerega je vložena vloga.
The quality/methodology of tests, where there are no standardised test methods, must be evaluated and the following characteristics, when available, of the methods described must be assessed:
Kadar ni na voljo nobenih standardnih testnih metod, je treba oceniti kakovost/metodologijo testov in naslednje značilnosti, če jih opisane metode vključujejo:
relevance; representativeness; sensitivity; specificity; reproducibility; interlaboratory validations; predictiveness.
relevantnost; zastopanost; občutljivost; specifičnost; obnovljivost; medlaboratorijske validacije; napovedljivost.
In interpreting the results of evaluations, Member States shall take into consideration possible elements of uncertainty in the information obtained during the evaluation, in order to ensure that the chances of failing to detect adverse effects or of underestimating their importance are reduced to a minimum.
Države članice pri razlagi rezultatov ocenjevanja upoštevajo možne elemente nezanesljivosti informacij, pridobljenih med ocenjevanjem, da zagotovijo, da je možnost neodkritja škodljivih učinkov ali podcenjevanja njihove pomembnosti čim manjša.
This shall be followed by a repeat evaluation, taking account of potential uncertainties in the critical data and of a range of use conditions that are likely to occur and resulting in a realistic worst-case approach, to determine whether it is possible that the initial evaluation could have been significantly different.
Temu sledi ponovno ocenjevanje, ki upošteva morebitno nezanesljivost pri kritičnih podatkih in obseg verjetnih razmer uporabe za realistični pristop za najhujši možni primer ter s katerim se določi možnost bistvenega odstopanja od prve ocene.
Member States shall evaluate each microbial plant protection product for which an application for authorisation is made in that Member State — the information evaluated for the micro-organism can be taken into account.
Države članice ocenijo vsako mikrobiološko fitofarmacevtsko sredstvo, za katero je bil vložena vloga za registracijo v navedeni državi članici – upoštevajo se lahko informacije, ocenjene pri mikroorganizmu.
Member States shall take into account the fact that any co-formulants might have an impact on the characteristics of the plant protection product compared to the micro-organism.
Države članice upoštevajo, da v primerjavi z mikroorganizmom katera koli pomožna snov v formulaciji lahko vpliva na lastnosti fitofarmacevtskega sredstva.
In evaluating applications and granting authorisations Member States shall consider the proposed practical conditions of use and in particular the purpose of use, the dose, the manner, frequency and timing of applications, and the nature and composition of the plant protection product.
Države članice pri ocenjevanju vlog in izdaji registracij upoštevajo predlagane praktične pogoje uporabe in zlasti namen uporabe, odmerek, način nanašanja, pogostost in časovni razpored nanašanja ter naravo in sestavo fitofarmacevtskega sredstva.
Whenever possible, Member States shall also take into account the principles of integrated pest control.
Države članice upoštevajo tudi načela integriranega varstva pred škodljivci, kadar koli je mogoče.
In the evaluation, Member States shall consider the agricultural, plant health or environmental (including climatic) conditions in the areas of use.
Pri ocenjevanju države članice upoštevajo razmere kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami) na območjih uporabe.
Where specific principles in Section 2 provide for the use of calculation models in the evaluation of a plant protection product, those models shall:
Kadar posebna načela iz oddelka 2 pri oceni fitofarmacevtskega sredstva določajo uporabo matematičnih modelov, ti modeli:
make a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions;
zagotavljajo najboljšo možno oceno vseh relevantnih postopkov, pri čemer se upoštevajo dejanski parametri in predpostavke;
be submitted to an evaluation as referred to in point 1.3;
se predložijo v oceno iz točke 1.3;
be reliably validated with measurements carried out under circumstances relevant for the use of the model;
se zanesljivo validirajo z meritvami v okoliščinah, relevantnih za uporabo modela;
be relevant to the conditions in the area of use;
so relevantni za razmere na območju uporabe;
be supported with details indicating how the model calculates estimates provided, and explanations of all the inputs to the model and details of how they have been derived.
podpirajo jih podrobni podatki o tem, kako se po modelu izračunajo dobljene ocene, in razlaga vseh podatkov, vnesenih v model, ter podrobnih podatkov o tem, kako so bili dobljeni.
The data requirements, specified in part B of the Annex to Regulation (EU) No 544/2011 and part B of the Annex to Regulation (EU) No 545/2011, contain guidance as to when and how certain information must be submitted and as to procedures that must be followed when preparing and evaluating a dossier.
Zahteve po podatkih iz dela B Priloge k Uredbi (EU) št. 544/2011 in dela B Priloge k Uredbi (EU) št. 545/2011 vsebujejo navodila, kdaj in kako je treba predložiti nekatere podatke, in postopke, po katerih je treba dokumentacijo pripraviti in oceniti.
Member States shall implement the following principles in the evaluation of the data and information submitted in support of applications, without prejudice to the general principles prescribed in Section 1:
Države članice pri ocenjevanju podatkov in informacij, predloženih v podporo vlogi, ter brez poseganja v splošna načela iz oddelka 1, izvajajo naslednja načela:
The identity of the micro-organism shall be clearly established.
Identiteta mikroorganizma se jasno ugotovi.
It shall be ensured that the appropriate data are provided to allow for checking the identity of the micro-organism at strain level in the plant protection product.
Zagotovijo se vsi ustrezni podatki, ki omogočajo preverjanje identitete mikroorganizma v fitofarmacevtskem sredstvu na ravni seva.
The identity of the micro-organism shall be evaluated on the strain level.
Identiteta mikroorganizma se oceni na ravni seva.
Where the micro-organism is either a mutant or a genetically modified organism [12], the specific differences from other strains within the same species shall be recorded.
Kadar je mikroorganizem mutant ali gensko spremenjen organizem [12], je treba navesti posebne razlike med sevi iste vrste.
Occurrence of resting stages shall be recorded.
Navesti je treba pojav faz mirovanja.
The deposition of the strain at an internationally recognised culture collection shall be checked.
Preveriti je treba, ali je sev v mednarodno priznani zbirki kultur.
Member States shall evaluate the detailed quantitative and qualitative information provided on the composition of the plant protection product, such as that concerning the micro-organism (see above), relevant metabolites/toxins, residual growth medium, co-formulants and microbial contaminants present.
Države članice ocenijo podrobne podatke o količini in kakovosti, predložene v zvezi s sestavo fitofarmacevtskega sredstva, npr. o prisotnem mikroorganizmu (glej zgoraj), relevantnih metabolitih/toksinih, ostankih rastnega gojišča, pomožnih snoveh v formulaciji in mikrobioloških onesnaževalcih.
The origin of the strain, where relevant, its natural habitat including indications on the natural background level, life cycle and the possibilities for survival, colonisation, reproduction and dispersal must be evaluated.
Oceniti je treba izvor seva, kadar je relevantno, njegov naravni habitat, vključno z navedbami ravni naravnega ozadja, življenjski cikel in možnosti za preživetje, kolonizacijo, razmnoževanje in razširjanje.
The ability of micro-organisms to adapt to the environment must be evaluated.
Oceniti je treba zmožnost mikroorganizma za prilagajanje okolju.
depending on the conditions (e.g. availability of substrates for growth and metabolism) micro-organisms can switch on or off the expression of given phenotypic traits;
odvisno od razmer (npr. razpoložljivost substratov za rast in presnovo) mikroorganizmi lahko vklopijo ali izklopijo izražanje danih fenotipskih lastnosti;
the microbial strains most adapted to the environment can survive and multiply better than the non-adapted strains.
okolju najbolj prilagojeni sevi mikroorganizmov lahko preživijo in se množijo bolje kot neprilagojeni sevi.
Adapted strains have a selective advantage and can form the majority within a population after a number of generations;
Prilagojeni sevi imajo selektivno prednost in so lahko po več rodovih večina populacije;
the relatively rapid multiplication of micro-organisms leads to a higher frequency of mutations.
razmeroma hitro množenje mikroorganizmov je vzrok pogostejših mutacij.
If a mutation is promoting survival in the environment, the mutant strain can become dominant;
Če je mutacija koristna za preživetje v okolju, mutantski sev lahko prevlada;
Therefore, where appropriate, information on the genetic stability of the micro-organism under the environmental conditions of proposed use must be evaluated, as well as information on the micro-organism’s capacity to transfer genetic material to other organisms and information on the stability of encoded traits.
Kadar je to primerno, je zato treba oceniti informacije o genski stabilnosti mikroorganizma v okoljskih razmerah predlagane uporabe, pa tudi informacije o zmožnosti mikroorganizma za prenos genskega materiala na druge organizme in informacije o stabilnosti kodiranih lastnosti.
The mode of action of the micro-organism shall be evaluated in as much detail as appropriate.
Ustrezno podrobno se oceni način delovanja mikroorganizma.
The possible role of metabolites/toxins for the mode of action shall be evaluated and when identified, the minimal effective concentration for each active metabolite/toxin shall be established.
Oceni se možna funkcija metabolitov/toksinov pri načinu delovanja, po ugotovitvi funkcije pa se določi najmanjša učinkovita koncentracija za vsak aktivni metabolit/toksin.
Aspects to be considered in the evaluation, are:
Pri ocenjevanju je treba upoštevati naslednje vidike:
antibiosis;
antibiozo;
induction of plant resistance;
indukcijo odpornosti rastlin;
interference with the virulence of a pathogenic target organism;
motnje z virulenco patogenega ciljnega organizma;
endophytic growth;
rast endofitov;
root colonisation;
kolonizacija korenine;
competition of ecological niche (e.g. nutrients, habitats);
konkurenčnost ekološke niše (npr. hranila, habitati);
parasitisation;
zmožnost parazitiranja;
In order to evaluate possible effects on non-target organisms, information on the micro-organism’s host specificity must be evaluated, taking into account the characteristics and properties described in (a) and (b).
Za oceno možnih učinkov na neciljne organizme je treba oceniti informacije o specifičnosti gostitelja mikroorganizma ob upoštevanju značilnosti in lastnosti iz odstavkov (a) in (b).
The ability of a micro-organism to be pathogenic for non-target organisms (humans, animals, and other non-target organisms) must be assessed.
Oceniti je treba zmožnost mikroorganizma, da je patogen za neciljne organizme (ljudi, živali in druge neciljne organizme).
Any relationship to known plant, animal or human pathogens that are species of the genus of the active and/or contaminating micro-organisms must be assessed.
Oceniti je treba kakršno koli povezavo z znanimi rastlinskimi, živalskimi ali človeškimi patogeni, ki so vrsta iz rodu aktivnih in/ali kontaminantnih mikroorganizmov.
For example, multiplication in humans depends upon the ability of the micro-organism to grow at the body temperature of the host.
Razmnoževanje v ljudeh je na primer odvisno od zmožnosti mikroorganizma, da raste pri telesni temperaturi gostitelja.
Some micro-organisms can only grow and be metabolically active at temperatures far below or above human body temperature, and therefore can not be pathogenic for humans.
Nekateri mikroorganizmi lahko rastejo in so metabolno aktivni samo pri temperaturah, ki so precej nižje ali višje od telesne temperature človeka, zato za ljudi ne morejo biti patogeni.
However, the route of entry of the micro-organism into the host (oral, inhalation, skin/wound) can also be the critical factor.
Pot vstopa mikroorganizma v gostitelja (oralno, vdihavanje, koža/rana) je lahko tudi kritični dejavnik.
Many micro-organisms produce antibiosis substances that cause normal interferences in the microbial community.
Številni mikroorganizmi proizvajajo protimikrobne snovi, ki povzročajo običajne motnje v mikrobiološki skupnosti.
Resistance to antimicrobial agents of importance for human and veterinary medicine must be assessed.
Oceniti je treba odpornost proti protimikrobnim sredstvom, pomembnim za humano in veterinarsko medicino.
The possibility for transfer of genes that code for resistance to antimicrobial agents must be evaluated.
Oceniti je treba možnost za prenos genov, ki kodirajo za odpornost proti protimikrobnim sredstvom.
Depending on the nature of the micro-organism and the formulation type, the technical properties of the plant protection product must be evaluated.
Oceniti je treba tehnične lastnosti fitofarmacevtskega sredstva glede na naravo mikroorganizma in tip formulacije.
Shelf-life and storage stability of the preparation must be evaluated, taking into account possible changes in composition such as growth of the micro-organism or of contaminating micro-organisms, production of metabolites/toxins, etc.
Oceniti je treba rok uporabnosti in stabilnost pri shranjevanju pripravka ob upoštevanju možnih sprememb v sestavi, npr. rast mikroorganizma ali kontaminantnih mikroorganizmov, proizvajanja metabolitov/toksinov itn.
Member States shall evaluate the physical and chemical properties of the plant protection product and the retention of these characteristics after storage and take into consideration:
Države članice ocenijo fizikalne in kemijske lastnosti fitofarmacevtskega sredstva in obstojnost teh značilnosti po shranjevanju, upoštevajo pa tudi:
where a suitable Food and Agriculture Organisation of the United Nations (FAO) specification exists, the physical and chemical properties addressed in that specification;
kadar obstaja ustrezna specifikacija Organizacije Združenih narodov za prehrano in kmetijstvo (FAO), fizikalne in kemijske lastnosti iz navedene specifikacije;
where no suitable FAO specification exists, all relevant physical and chemical properties for the formulation referred to in the Manual on the development and use of FAO and World Health Organisation (WHO) specifications for pesticides.
kadar ni ustrezne specifikacije FAO, vse relevantne fizikalne in kemijske lastnosti formulacije iz Priročnika za razvoj in uporabo specifikacij FAO in Svetovne zdravstvene organizacije za pesticide.
Where the proposed label claims include requirements or recommendations for use of the preparation with other plant protection products or adjuvants as a tank mix, and/or where the proposed label includes indications concerning the compatibility of the preparation with other plant protection products as a tank mix, those plant protection products or adjuvants must be physically and chemically compatible in the tank mix.
Kadar se na predlagani oznaki zahteva ali priporoča uporaba pripravka z drugimi fitofarmacevtskimi sredstvi ali dodatki v mešanici v tanku škropilnice in/ali kadar predlagana oznaka navaja združljivost pripravka z drugimi fitofarmacevtskimi sredstvi v mešanici v tanku škropilnice, morajo biti navedena fitofarmacevtska sredstva ali dodatki v mešanici fizikalno in kemično združljivi.
Biological compatibility must also be demonstrated for tank-mixtures, i.e. it must be shown that each plant protection product in the mixture performs as expected and that no antagonism occurs.
Dokazati je treba tudi biološko združljivost mešanice v tanku škropilnice, tj. pokazati je treba, da se vsako fitofarmacevtsko sredstvo v mešanici obnaša po pričakovanju in da ni nezdružljivosti.
In the evaluation criteria relating to process control, good manufacturing practice, operational practices, process flows, cleaning practices, microbial monitoring and hygiene conditions should be taken into account to ensure good quality of the micro-organism.
Za zagotovitev dobre kakovosti mikroorganizma je treba upoštevati merila ocenjevanja, ki se nanašajo na kontrolo postopka (izdelave), dobro proizvodno prakso, operativne prakse, potek procesa, čistilne postopke, spremljanje mikroorganizmov in higienske razmere.
The quality, stability, purity, etc., of the micro-organism must be addressed in the quality control system.
S sistemom nadzora kakovosti pa je treba nadzorovati kakovost, stabilnost, čistočo itn. mikroorganizma.
Member States shall evaluate whether significant damage, loss or inconvenience could occur under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use if the plant protection product were not used.
Države članice ocenijo, ali bi na območju predlagane uporabe lahko nastala znatna škoda, izguba ali težava v razmerah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami), če se fitofarmacevtsko sredstvo ne uporabi.
Member States shall evaluate the efficacy data provided for in part B of the Annex to Regulation (EU) No 545/2011 on the plant protection product having regard to the degree of control or the extent of the effect desired and having regard to relevant experimental conditions such as:
Države članice ocenijo zahtevane podatke o učinkovitosti fitofarmacevtskega sredstva iz dela B Priloge k Uredbi Komisije (EU) št. 545/2011 ob upoštevanju stopnje nadzora ali obsega želenega učinka ter relevantnih eksperimentalnih razmer, kot so:
the choice of the crop or cultivar;
izbira kulture ali kultivarja;