natgillin/translations-raw huggingface dataset:
The results of any experimental studies must be reported.
Navedejo se rezultati vseh eksperimentalnih študij.
It shall be stated by which way an uptake of the micro-organism, or its metabolites (especially toxins) may occur (e.g. contact, stomach, inhalation).
Navede se, na kakšen način lahko pride do vnosa mikroorganizma ali njegovih metabolitov (zlasti toksinov) (npr. stik, želodec, vdihavanje).
It must also be stated whether or not the micro-organism or its metabolites are translocated in plants and, where relevant, how this translocation takes place.
Prav tako je treba navesti, ali se mikroorganizem ali njegovi metaboliti premeščajo v rastlinah in, kadar je to relevantno, kako to premeščanje poteka.
In case of pathogenic effect on the target organism, infective dose (the dose needed to cause infection with the intended effect on a target species) and transmissibility (possibility of spread of the micro-organism in the target population, but also from one target species to another (target) species) after application under the proposed condition of use shall be indicated.
V primeru patogenega učinka na ciljni organizem se navedeta kužni odmerek (odmerek, potreben za povzročitev okužbe z načrtovanim učinkom na ciljni vrsti) in prenosljivost (možnost širitve mikroorganizma v ciljni populaciji ter z ene ciljne vrste na drugo (ciljno) vrsto) po uporabi pri predlaganih pogojih uporabe.
Host specificity range and effects on species other than the target harmful organism
Razpon specifičnih gostiteljev in učinki na vrste, ki niso ciljni škodljivi organizmi
Any available information on the effects on non-target organisms within the area to which the micro-organism may spread shall be given.
Navedejo se kakršne koli razpoložljive informacije o učinkih na neciljne organizme znotraj območja, na katerem se mikroorganizem lahko razširi.
The occurrence of non-target organisms being either closely related to the target species or being especially exposed shall be indicated.
Navede se prisotnost neciljnih mikroorganizmov, ki so bodisi v tesni povezavi s ciljno vrsto bodisi posebej izpostavljeni.
Any experience of the toxic effect of the active substance or its metabolic products on humans or animals, of whether the organism is capable of colonising or invading humans or animals (including immunosuppressed individuals) and whether it is pathogenic shall be stated.
Navedejo se kakršni koli primeri toksičnega učinka aktivne snovi ali njenih metabolnih produktov na ljudi ali živali, ali je organizem sposoben kolonizacije ali vdora v ljudi ali živali (vključno z imunsko oslabljenimi posamezniki) in ali je patogen.
Any experience of whether the active substance or its products may irritate skin, eyes or respiratory organs of humans or animals and whether it is allergenic in contact with skin or when inhaled shall be stated.
Navedejo se kakršni koli primeri, kjer lahko aktivna snov ali njeni proizvodi dražijo kožo, oči ali dihalne organe ljudi ali živali in ali deluje alergeno ob stiku s kožo ali z vdihavanjem.
Information on the life cycle of the micro-organism, described symbiosis, parasitism, competitors, predators, etc. including host organisms, as well as vectors for viruses, must be presented.
Navesti je treba informacije o življenjskem ciklusu mikroorganizma, opis simbioze, zajedalstva, tekmecev, plenilcev itd., vključno z gostitelji, ter virusne vektorje.
The generation time and the type of reproduction of the micro-organism must be stated.
Navesti je treba generacijski čas in način razmnoževanja mikroorganizma.
Information on the occurrence of resting stages and their survival time, their virulence and infection potential must be provided.
Predložiti je treba informacije o nastopu faz mirovanja in njihovem času preživetja, njihovi virulenci ter zmožnosti okužbe.
The potential of the micro-organism to produce metabolites, including toxins that are of concern for human health and/or the environment, in its different development stages after the release, must be indicated.
Navesti je treba zmožnost mikroorganizma za tvorjenje metabolitov, vključno s toksini, ki vzbujajo skrb za zdravje ljudi in/ali za okolje, v različnih razvojnih fazah po sprostitvi.
The persistence of the micro-organism and information on its life cycle under the typical environmental conditions of use must be indicated.
Navesti je treba obstojnost mikroorganizma in informacije o njegovem življenjskem ciklusu v tipičnih okoljskih razmerah uporabe.
In addition, any particular sensitivity of the micro-organism to certain compartments of the environment (e.g. UV light, soil, water) must be stated.
Poleg tega je treba navesti kakršno koli posebno občutljivost mikroorganizma na nekatere dele okolja (npr. UV svetloba, tla, voda).
The environmental requirements (temperature, pH, humidity, nutrition requirements, etc.) for survival, reproduction, colonisation, damage (including human tissues) and effectiveness of the micro-organism must be stated.
Navesti je treba okoljske razmere (temperatura, pH, vlaga, hranilne potrebe itd.) za preživetje, razmnoževanje, koloniziranje, poškodbe (vključno s človeškimi tkivi) in učinkovitost mikroorganizma.
The presence of specific virulence factors shall be indicated.
Navede se prisotnost posebnih dejavnikov virulence.
The temperature range at which the micro-organism grows must be determined, including minimum, maximum and optimum temperatures.
Določiti je treba temperaturni razpon, v katerem mikroorganizem raste, vključno z najnižjo, najvišjo in najugodnejšo temperaturo.
This information is of particular value as a trigger for studies of effects on human health (Section 5).
Te informacije so izrednega pomena kot povod za študije o učinkih na zdravje ljudi (oddelek 5).
The possible effect of factors such as temperature, UV light, pH, and the presence of certain substances on the stability of relevant toxins must also be stated.
Prav tako je treba navesti morebitne učinke dejavnikov, kot so temperatura, UV svetloba, pH in prisotnost nekaterih snovi, na stabilnost relevantnih toksinov.
Information on possible dispersal routes of the micro-organism (via air as dust particles or aerosols, with host organisms as vectors, etc.), under typical environmental conditions relevant to the use, must be provided.
Navesti je treba informacije o možnih načinih širjenja mikroorganizma (po zraku kot prašni delci ali aerosoli, z organizmi gostitelja kot vektorji itd.) v tipičnih okoljskih razmerah, relevantnih za uporabo.
The possible existence of one or more species of the genus of the active and/or, where relevant, contaminating micro-organisms known to be pathogenic to humans, animals, crops or other non-target species and the type of disease caused by them shall be indicated.
Navede se morebitna prisotnost ene ali več vrst razreda aktivnih in/ali, kadar je to relevantno, kontaminantnih mikroorganizmov, za katere je znano, da so patogeni za ljudi, živali, kulture ali druge neciljne vrste, in vrsto bolezni, ki jo povzročajo.
It shall be stated whether it is possible, and if so, by which means to clearly distinguish the active micro-organism from the pathogenic species.
Navede se, na kakšen način je mogoče, če sploh, jasno razlikovati med aktivnim mikroorganizmom in patogeno vrsto.
Where appropriate, information on genetic stability (e.g. mutation rate of traits related to the mode of action or uptake of exogenous genetic material) under the environmental conditions of proposed use must be provided.
Kadar je primerno, je treba navesti informacije o genski stabilnosti (npr. mutacijska stopnja lastnosti, ki se nanašajo na način delovanja ali vnos eksogenega genskega materiala) v okoljskih razmerah predlagane uporabe.
Information must also be provided on the micro-organism’s capacity to transfer genetic material to other organisms as well as its capacity to being pathogenic for plants, animals or man.
Prav tako je treba navesti informacije o zmožnosti mikroorganizma, da prenaša genski material na druge organizme, ter njegovo zmožnost patogenega delovanja na rastline, živali ali ljudi.
If the micro-organism carries relevant additional genetic elements, the stability of the encoded traits shall be indicated.
Če mikroorganizem nosi dodatne relevantne genske elemente, se navede stabilnost kodiranih lastnosti.
If other strains belonging to the same microbial species as the strain subject to the application are known to produce metabolites (especially toxins) with unacceptable effects on human health and/or the environment during or after application, the nature and structure of this substance, its presence inside or outside the cell and its stability, its mode of action (including external and internal factors of the micro-organism necessary to action) as well as its effect on humans, animals or other non-target species shall be provided.
Če je za druge seve, ki sodijo v isto mikrobiološko vrsto kot sev, za katerega je predložena vloga za registracijo, znano, da tvorijo metabolite (zlasti toksine) z nedopustnimi učinki na zdravje ljudi in/ali okolje med uporabo ali po njej, se navedejo narava in sestava te snovi, njena znotrajcelična in zunajcelična prisotnost ter njena stabilnost, način delovanja (vključno z zunanjimi in notranjimi dejavniki mikroorganizma, potrebnimi za delovanje) in tudi njen učinek na ljudi, živali ali druge neciljne vrste.
The conditions under which the micro-organism produces the metabolite(s) (especially toxin(s)) must be described.
Opisati je treba pogoje, pod katerimi mikroorganizem tvori metabolite (zlasti toksine).
Any available information on the mechanism by which the micro-organisms regulate the production of the(se) metabolite(s) shall be provided.
Navedejo se kakršne koli razpoložljive informacije o mehanizmu, s katerim mikroorganizmi uravnavajo tvorjenje teh metabolitov.
Any available information on the influence of the produced metabolites on the micro-organism’s mode of action shall be provided.
Navedejo se kakršne koli razpoložljive informacije o vplivu nastalih metabolitov na način delovanja mikroorganizma.
Antibiotics and other anti-microbial agents
Antibiotiki in druga protimikrobna sredstva
Many micro-organisms produce some antibiotic substances.
Številni mikroorganizmi tvorijo antibiotične snovi.
Interference with the use of antibiotics in human or veterinary medicine must be avoided at any stage of the development of a microbial plant protection product.
Interferencam z uporabo antibiotikov v humani ali veterinarski medicini se je treba izogibati v kateri koli razvojni fazi mikrobiološkega fitofarmacevtskega sredstva.
Information on the micro-organism’s resistance or sensitivity to antibiotics or other anti-microbial agents must be provided, in particular the stability of the genes coding for antibiotic resistance, unless it can be justified that the micro-organism has no harmful effects on human or animal health, or that it can not transfer its resistance to antibiotics or other anti-microbial agents.
Zagotoviti je treba informacije o odpornosti ali občutljivosti mikroorganizma na antibiotike ali druga protimikrobna sredstva, zlasti stabilnost genov, kodiranih za odpornost proti antibiotikom, razen če se lahko utemelji, da mikroorganizem nima škodljivih učinkov na zdravje ljudi ali živali ali ne more prenašati svoje odpornosti proti antibiotikom ali drugim protimikrobnim sredstvom.
The information provided must describe the intended purposes for which preparations containing the micro-organism are used, or are to be used and the dose and manner of their use or proposed use.
Navedene informacije morajo opisovati predvidene namene, za katere se uporabljajo ali se bodo uporabljali pripravki, ki vsebujejo mikroorganizem, ter odmerek in način njihove uporabe ali predlagane uporabe.
The information provided must specify the normal methods and precautions to be followed in the handling, storage and transport of the micro-organism.
Navedene informacije morajo natančno določati običajne postopke in varnostne ukrepe, ki jih je treba upoštevati pri ravnanju, shranjevanju in prevažanju mikroorganizma.
The studies, data and information submitted, must demonstrate the suitability of measures proposed for use in emergency situations.
Navedene študije, podatki in informacije morajo prikazovati ustreznost ukrepov, predlaganih za uporabo v izrednih razmerah.
The information and data referred to are required for each micro-organism, except where otherwise specified.
Navedene informacije in podatki so obvezni za vsak mikroorganizem, če ni določeno drugače.
Function
Delovanje
The biological function must be specified from among the following:
Biološko delovanje je treba opredeliti z enim od naslednjih delovanj:
control of bacteria,
zatiranje bakterij,
control of fungi,
zatiranje gliv,
control of insects,
zatiranje mrčesa,
control of mites,
zatiranje pršic,
control of molluscs,
zatiranje mehkužcev,
control of nematodes,
zatiranje nematod,
control of weeds,
zatiranje plevela,
The field(s) of use, existing and proposed, for preparations containing the micro-organism must be specified from among the following:
Obstoječa in predlagana področja uporabe za pripravke, ki vsebujejo mikroorganizem, je treba podrobno določiti med naslednjimi področji uporabe:
field use, such as agriculture, horticulture, forestry, and viticulture,
na prostem, npr. v poljedelstvu, vrtnarstvu, gozdarstvu in vinogradništvu,
weed control on non-cultivated areas,
zatiranje plevela na nekmetijskih površinah,
home gardening,
urejanje hišnih vrtov,
house plants,
sobne rastline,
stored products,
skladiščenje proizvodov,
Crops or products protected or treated
Varovane ali tretirane kulture ali proizvodi
Details of existing and intended use in terms of crops, groups of crops, plants, or plant products protected, must be provided.
Navesti je treba podrobne informacije o obstoječi in predvideni uporabi v smislu varstva kultur, skupin kultur, rastlin ali rastlinskih proizvodov.
Method of production and quality control
Proizvodni postopek in nadzor kakovosti
Full information on how the micro-organism is produced in bulk must be provided.
Navesti je treba izčrpne informacije o načinu serijske proizvodnje mikroorganizma.
Both production method/process and product must be subject to a continuous quality control by the applicant.
Vlagatelj mora neprekinjno nadzorovati kakovost proizvodnega postopka in proizvoda.
In particular, the occurrence of spontaneous changing of major characteristics of the micro-organism and of the absence/presence of significant contaminants shall be monitored.
Spremljajo se zlasti spontane spremembe glavnih značilnosti mikroorganizma in odsotnosti/prisotnosti pomembnih kontaminantov.
The quality assurance criteria for the production shall be submitted.
Predložijo se merila za zagotavljanje kakovosti.
The techniques used to ensure a uniform product, and the assay methods for its standardisation, maintenance and purity of the micro-organism must be described and specified (e.g. HACCP).
Tehnike, uporabljene za zagotavljanje enotnosti proizvoda, in preskušene metode za njegovo standardizacijo, vzdrževanje in čistost mikroorganizma je treba opisati in natančno določiti (npr. HACCP).
Information on the occurrence or possible occurrence of the development of resistance of the target organism(s)
Informacije o pojavu ali možnem pojavu razvoja odpornosti ciljnih organizmov
Available information on the possible occurrence of the development of resistance or cross-resistance of the target organism(s) must be provided.
Navesti je treba razpoložljive informacije o možnem pojavu razvoja odpornosti ali navzkrižne odpornosti ciljnih organizmov.
Where possible, appropriate management strategies shall be described.
Kadar je mogoče, se opišejo ustrezne strategije vodenja.
Methods to prevent loss of virulence of starting cultures shall be provided.
Navedejo se metode preprečevanja izgube virulence izvornih kultur mikroorganizma.
In addition, any method, if available, that could prevent the micro-organism from losing its effects on the target species must be described.
Poleg tega je treba opisati kakršno koli metodo, če je na voljo, s katero se lahko prepreči izguba sposobnosti učinkovanja mikroorganizma na ciljne vrste.
A safety data sheet pursuant to Article 31 of Regulation (EC) No 1907/2006 must be provided for each micro-organism.
Za vsak mikroorganizem je treba v skladu s členom 31 Uredbe (ES) št. 1907/2006 predložiti varnostni list.
In many cases the preferred or sole means of safe disposal of micro-organisms, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator.
V številnih primerih je najustreznejši ali edini način varnega uničenja mikroorganizmov, kontaminiranih materialov ali embalaže nadzorovani sežig v sežigalni napravi, ki ima za to uradno dovoljenje.
Methods to dispose safely of the micro-organism or, where necessary, to kill it prior to disposal, and methods to dispose of contaminated packaging and contaminated materials, must be fully described.
Postopke varne odstranitve mikroorganizma ali, kadar je to potrebno, njegovega uničenja pred odstranitvijo, in postopke odstranitve kontaminirane embalaže ter kontaminiranih materialov je treba izčrpno opisati.
Data must be provided for such methods to establish their effectiveness and safety.
Podatki o takšnih postopkih so obvezni za zagotovitev njihove učinkovitosti in varnosti.
Information on procedures for rendering the micro-organism harmless in the environment (e.g. water or soil) in case of an accident must be provided.
Predložiti je treba informacije o postopkih, s katerimi se v primeru nesreče mikroorganizem pretvori v takšnega, ki ni škodljiv okolju (npr. v vodi ali na tleh).
Post-approval monitoring might be considered for all areas of risk assessment.
Spremljanje po odobritvi se lahko nanaša na vsa področja ocene tveganja.
This is particularly the case when (strains of) micro-organisms that are non-indigenous to the intended area of application are considered for approval.
Tako je zlasti v primerih, ko se za odobritev preučujejo mikroorganizmi (njihovi sevi), ki niso avtohtoni na predvidenem območju uporabe.
The applicability of any internationally recognised method must be reported.
Poročati je treba o uporabnosti kakršne koli mednarodno priznane metode.
Data on specificity, linearity, accuracy and repeatability, as defined in points 4.1 and 4.2 of Part A of this Annex, are also required for methods used to analyse micro-organisms and their residues.
Prav tako so za metode, ki se uporabljajo za analizo mikroorganizmov in njihovih ostankov, potrebni podatki o specifičnosti, linearnosti, natančnosti in ponovljivosti, kot so določeni v točkah 4.1 in 4.2 dela A te priloge.
Impurities, Metabolites, Relevant metabolites, Residues
Nečistoče, metaboliti, relevantni metaboliti, ostanki
As defined in Regulation (EC) No 1107/2009
Kakor so opredeljeni v Uredbi (ES) št. 1107/2009
Impurities, as defined above, that are of concern for human or animal health and/or the environment
Nečistoče, kakor so opredeljene zgoraj, ki vzbujajo skrb za zdravje ljudi ali živali in/ali okolje
samples of the micro-organism as manufactured;
mikroorganizma, kakor se proizvaja;
analytical standards of relevant metabolites (especially toxins) and all other components included in the residue definition;
analitskih standardov relevantnih metabolitov (zlasti toksinov) in vseh drugih sestavin, vključenih v opredeljenem ostanku;
Methods for the identification of the micro-organism,
Metode za opredelitev mikroorganizma.
Methods for providing information on possible variability of seed stock/active micro-organism,
Metode za zagotavljanje informacij o morebitni raznolikosti izvorne kulture/aktivnega mikroorganizma.
Methods to differentiate a mutant of the micro-organism from the parent wild strain,
Metode za razlikovanje med mutantom mikroorganizma in starševskim divjim sevom.
Methods for the establishment of purity of seed stock from which batches are produced and methods to control that purity,
Metode za ugotavljanje čistosti izvorne kulture, iz katere se proizvajajo serije, in metode za nadzor navedene čistosti.
Methods to determine the content of the micro-organism in the manufactured material used for the production of formulated products and methods to show that contaminating micro-organisms are controlled to an acceptable level,
Metode za opredeljevanje vsebnosti mikroorganizma v uporabljeni tehnični snovi, uporabljeni za izdelavo formuliranih pripravkov, in metode, s katerimi se prikaže, da se kontaminantni mikroorganizmi nadzorovano zadržujejo na dopustni ravni.
Methods for the determination of relevant impurities in the manufactured material,
Metode za opredelitev relevantnih nečistoč v proizvodnem materialu.
Methods to control the absence and to quantify (with appropriate limits of determination) the possible presence of any human and mammalian pathogens,
Metode za nadziranje odsotnosti in količinsko opredeljevanje (z ustreznimi mejami določitve) morebitne prisotnosti kakršnih koli človeških patogenov in patogenov sesalcev.
Methods to determine storage stability, shelf-life of the micro-organism, if appropriate.
Metode za določitev stabilnosti pri shranjevanju in roka uporabnosti mikroorganizma, če je primerno.
Methods to determine and quantify residues (viable or non-viable)
Metode za določitev in količinsko opredeljevanje ostankov (živih ali neživih)
relevant metabolites (especially toxins).
relevantnih metabolitov (zlasti toksinov)
on and/or in crop, in foodstuffs and feeding stuffs, in animal and human body tissues and fluids, in soil, in water (including drinking water, ground water and surface water) and in air where relevant.
na in/ali v kulturah, živilih in krmi, v živalskem in človeškem tkivu ter tekočinah, na tleh, v vodi (vključno s pitno vodo, podtalnico in površinskimi vodami) in zraku, kadar je to relevantno.
Analytical methods for amount or activity of proteinaceous products shall also be included, e.g. by testing exponential cultures and culture supernatants in an animal cell bioassay.
Vključijo se tudi analitske metode za določanje količine ali delovanja proteinskih produktov, npr. s testiranjem eksponentnih kultur in supernatantov kulture v živalskih celičnih biotestih.
Available information based on the properties of the micro-organism and corresponding organisms (Sections 1, 2 and 3), including health and medical reports may be sufficient for a decision whether the micro-organism would cause health effects (infectious/pathogenic/toxic) in humans or not.
Razpoložljive informacije, ki temeljijo na lastnostih mikroorganizma in ustreznih organizmov (oddelki 1, 2 in 3), vključno z zdravstvenimi in medicinskimi poročili, lahko zadoščajo za odločitev, ali lahko mikroorganizem učinkuje (kužno/patogeno/toksično) na zdravje ljudi.
The information provided, taken together with that provided for one or more preparations containing the micro-organism, must be sufficient to permit an evaluation to be made as to the risks for man, directly and/or indirectly associated with the handling and use of plant protection products containing the micro-organism, and the risk for man handling treated products, and the risk for man arising from residual traces or contaminants remaining in food and water.
Predložene informacije, skupaj z informacijami, predloženimi za enega ali več pripravkov, ki vsebujejo mikroorganizem, morajo zadoščati za oceno tveganja za ljudi, neposredno in/ali posredno povezane z ravnanjem in uporabo fitofarmacevtskih sredstev, ki vsebujejo mikroorganizem, in tveganje za ljudi, ki ravnajo s tretiranimi proizvodi, in tveganje za ljudi zaradi sledov ostankov ali kontaminantov v živilih in vodi.
permit a decision to be made as to whether, or not, the micro-organism can be approved,
odločitev o odobritvi mikroorganizma,
specify risk and safety phrases (once introduced) for the protection of man, animals and the environment to be included on packaging (containers),
natančno določitev stavkov o nevarnosti in opozorilnih stavkov (takoj, ko so določeni) za zaščito ljudi, živali in okolja, ki morajo biti na embalaži (posodah),