natgillin/translations-raw huggingface dataset:
The appropriate test procedures and criteria used for identification (e.g. morphology, biochemistry, serology, molecular identification) must be provided.
Navesti je treba primerne preskusne postopke in merila, uporabljena za opredelitev (npr. morfološka, biokemijska, serološka, molekularna opredelitev).
Common name or alternative and superseded names and code names used during the development, if any, must be provided.
Navesti je treba splošno ali alternativno ime ter nadomestna in kodna imena, ki se uporabljajo med razvojem, če obstajajo.
The minimum and maximum content of the micro-organism in the material used for manufacturing of formulated products, must be reported.
Navesti je treba najmanjšo in največjo vsebnost mikroorganizma v snovi, uporabljeni za proizvodnjo formuliranih proizvodov.
The content shall be expressed in appropriate terms, such as number of active units per volume or weight or any other manner that is relevant to the micro-organism.
Vsebnost se izrazi v primernih enotah, kot je število aktivnih enot na volumen ali težo ali kateri koli drug način, ki ustreza mikroorganizmu.
Where the information provided relates to a pilot plant production system, the information required must again be provided to the Commission and the Member States once industrial scale production methods and procedures have stabilised, if production changes result in a changed specification of purity.
Kadar so navedene informacije povezane s pilotno proizvodnjo, je treba Komisiji in državam članicam potrebne informacije ponovno predložiti, ko se metode in postopki industrijske proizvodnje stabilizirajo, če se zaradi sprememb v proizvodnji spremeni specifikacija čistosti.
The level and nature of acceptable contaminants shall be judged from a risk assessment point of view, by the competent authority.
Količino in naravo dopustnih kontaminantov določi pristojni organ glede na oceno tveganja.
If possible and appropriate, the identity and maximum content of all contaminating micro-organisms, expressed in the appropriate unit, must be reported.
Kadar je to mogoče in primerno, je treba navesti opredelitev ter največjo vsebnost vseh kontaminantnih mikroorganizmov v primernih enotah.
The information on identity must be provided where possible as outlined in point 1.3 of Part B of this Annex.
Informacije o opredelitvi je treba, kadar je mogoče, navesti, kot je opisano v točki 1.3 dela B te priloge.
Relevant metabolites (i.e. if expected to be of concern to human health and/or the environment) known to be formed by the micro-organism shall be identified and characterised at different states or growth stages of the micro-organism (see point (viii) of this introduction).
Opredelitev in karakterizacija relevantnih metabolitov (tj. če se pričakuje, da so pogojno nevarni za zdravje ljudi in/ali okolje), za katere je znano, da jih povzročajo mikroorganizmi, se izvedeta na različnih stopnjah rasti ali razvoja mikroorganizma (glej točko (viii) tega uvoda).
Where relevant detailed information on all components such as condensates, culture medium, etc. must be provided.
Kadar je ustrezno, je treba navesti podrobne informacije o vseh sestavinah, kot so kondenzati, gojišče itd.
In the case of chemical impurities that are relevant for human health and/or the environment, the identity and maximum content, expressed in appropriate terms, must be provided.
V primeru kemijskih nečistoč, ki so pomembne za zdravje ljudi in/ali okolje, je treba navesti njihovo opredelitev in največjo vsebnost v primernih enotah.
In the case of additives, the identity and content in g/kg must be provided.
V primeru aditivov je treba navesti opredelitev in vsebnost v g/kg.
The information on identity of chemical substances such as additives must be provided as outlined in point 1.10 of Part A of this Annex.
Informacije o opredelitvi kemijskih snovi, kot so aditivi, je treba navesti, kot je opisano v točki 1.10 dela A te priloge.
Where relevant, the same data as outlined in point 1.11 of Part A of this Annex have to be reported, using the appropriate units.
Kadar je ustrezno, je treba navesti enake podatke, kot so opisani v točki 1.11 dela A te priloge, pri čemer je treba uporabiti primerne enote.
Familiarity, interpreted as the availability of relevant knowledge of the micro-organism, shall be presented.
Predstavi se poznavanje, ki se razlaga kot razpoložljivost ustreznih spoznanj o mikroorganizmu.
The historical background of the micro-organism and its use (tests/research projects or commercial use) must be provided.
Navesti je treba zgodovinsko ozadje mikroorganizma in njegove uporabe (preskusi/raziskovalni projekti ali uporaba v komercialne namene).
The natural occurrence of the micro-organism in the relevant environment shall be given if possible at strain level.
Če je mogoče, se naravna prisotnost mikroorganizma v ustreznem okolju navede na ravni seva.
In the case of a mutant, or a genetically modified micro-organism, detailed information should be provided on its production and isolation and on the means by which it can be clearly distinguished from the parent wild strain.
V primeru mutanta ali gensko spremenjenega mikroorganizma je treba navesti podrobne informacije o njegovem pridobivanju in izolaciji ter načinu, po katerem ga je mogoče jasno razlikovati od starševskega divjega seva.
Where relevant, details of harmful organisms against which protection is afforded, must be provided.
Kadar je ustrezno, je treba navesti podrobne informacije o škodljivih organizmih, pred katerimi je zagotovljena zaščita.
If relevant, information on the site of infection and mode of entry into the target organism and its susceptible stages shall be given.
Kadar je ustrezno, se navedejo informacije o mestu okužbe in načinu vnosa v ciljni organizem ter fazah njegove dovzetnosti.
The results of any experimental studies must be reported.
Navesti je treba rezultate vseh eksperimentalnih študij.
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 ustrezno, 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 infektivni 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 nanosu pri predlaganih pogojih uporabe.
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 vse 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 organizmov, ki so tesno povezani s ciljno vrsto ali so ji posebej izpostavljeni.
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, v katerih lahko aktivna snov ali njeni proizvodi dražijo kožo, oči ali dihalne organe ljudi ali živali ali v katerih delujejo 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 ciklu mikroorganizma, opis simbioze, zajedavstva, tekmecev, plenilcev itd., vključno z gostitelji, ter virusne vektorje.
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 so pogojno nevarni za zdravje ljudi in/ali 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 ciklu v tipičnih okoljskih razmerah uporabe.
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 zahteve (temperatura, pH, vlaga, hranilne potrebe itd.) za preživetje, razmnoževanje, koloniziranje, poškodbe (vključno s človeškimi tkivi) in učinkovitost mikroorganizma.
This information is of particular value as a trigger for studies of effects on human health (Section 5).
Te informacije so zelo pomembne pri odločanju o izvedbi študij o učinkih na zdravje ljudi (oddelek 5).
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 gostitelji 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.
Navedeta se morebitna prisotnost ene ali več vrst rodu aktivnih in/ali, kadar je ustrezno, kontaminantnih mikroorganizmov, za katere je znano, da so patogeni za ljudi, živali, kulture ali druge neciljne vrste, in vrsta bolezni, ki jo povzročajo.
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 njegovi zmožnosti patogenega delovanja na rastline, živali ali ljudi.
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 vložena vloga za registracijo, znano, da med uporabo ali po njej tvorijo metabolite (zlasti toksine) z nedopustnimi učinki na zdravje ljudi in/ali okolje, se navedejo narava ter sestava te snovi, njena znotrajcelična in zunajcelična prisotnost ter njena stabilnost, način delovanja (vključno z zunanjimi in notranjimi dejavniki mikroorganizma, potrebnimi za delovanje) ter njen učinek na ljudi, živali ali druge neciljne vrste.
Any available information on the mechanism by which the micro-organisms regulate the production of the(se) metabolite(s) shall be provided.
Navedejo se vse 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 vse razpoložljive informacije o vplivu nastalih metabolitov na način delovanja mikroorganizma.
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.
V vseh razvojnih fazah mikrobiološkega fitofarmacevtskega sredstva je treba preprečiti poseganje v uporabo antibiotikov v humani ali veterinarski medicini.
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.
Predložiti 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 da ne more prenašati svoje odpornosti na antibiotike ali druga protimikrobna sredstva.
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.
Predložene informacije morajo vključevati opis predvidenih namenov, za katere se uporabljajo ali se bodo uporabljali pripravki, ki vsebujejo mikroorganizem, ter odmerka in načina 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 ter prevažanju mikroorganizma.
The studies, data and information submitted, must demonstrate the suitability of measures proposed for use in emergency situations.
Predložene študije, podatki in informacije morajo dokazovati ustreznost predlaganih ukrepov, ki se uporabljajo v izrednih razmerah.
The biological function must be specified from among the following:
Biološko delovanje je treba določiti glede na naslednje:
control of insects,
zatiranje žuželk,
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 določiti glede na naslednje:
field use, such as agriculture, horticulture, forestry, and viticulture,
na prostem, npr. v poljedelstvu, hortikulturi, gozdarstvu in vinogradništvu,
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 glede na varovane kulture, skupine kultur, rastline ali rastlinske proizvode.
Both production method/process and product must be subject to a continuous quality control by the applicant.
Vlagatelj mora stalno nadzorovati kakovost proizvodnega postopka in proizvoda.
Where possible, appropriate management strategies shall be described.
Kadar je mogoče, se opišejo ustrezne strategije ravnanja.
Methods to prevent loss of virulence of starting cultures shall be provided.
Navedejo se metode za preprečevanje 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, kadar je na voljo, s katero se lahko prepreči izguba sposobnosti učinkovanja mikroorganizma na ciljne vrste.
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.
Pogosto je najustreznejši ali edini način varnega uničenja mikroorganizmov, kontaminiranih snovi 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 po potrebi njegovega uničenja pred odstranitvijo ter postopke odstranitve kontaminirane embalaže in kontaminiranih snovi je treba izčrpno opisati.
Data must be provided for such methods to establish their effectiveness and safety.
Podatke o takšnih postopkih je treba navesti, da se določita njihova učinkovitost in varnost.
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 obliko, ki ni škodljiva za okolje (npr. vodi ali tleh).
The provisions of this Section only cover analytical methods required for post-registration control and monitoring purposes.
Določbe tega oddelka veljajo le za analitske metode, potrebne za nadzor in spremljanje po registraciji.
This is particularly the case when (strains of) micro-organisms that are non-indigenous to the intended area of application are considered for approval.
To velja zlasti v primerih, v katerih se za odobritev preučujejo mikroorganizmi (njihovi sevi), ki niso avtohtoni na predvidenem območju uporabe.
For analytical methods used for generation of data as required in this Regulation or for other purposes the applicant has to provide a justification for the method used;
V zvezi z analitskimi metodami, ki se uporabljajo za pridobivanje podatkov v skladu s to uredbo ali za druge namene, mora vlagatelj utemeljiti uporabljeno metodo;
where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes.
za takšne metode se po potrebi pripravijo ločene smernice na podlagi enakih zahtev, kakor so določene za metode za namene nadzora in spremljanja po registraciji.
Descriptions of methods must be provided and include details of equipment, materials and conditions used.
Predložiti je treba opise metod, ki vključujejo podrobnosti o uporabljeni opremi, snoveh in pogojih.
The applicability of any internationally recognised method must be reported.
Navesti je treba informacije o uporabnosti kakršne koli mednarodno priznane metode.
As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment.
Kolikor je to mogoče, je treba za izvajanje teh metod uporabljati najenostavnejši pristop, s katerim so povezani najnižji stroški in pri katerem se uporabi splošno dostopna oprema.
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 je treba za metode, ki se uporabljajo za analizo mikroorganizmov in njihovih ostankov, navesti podatke 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
Impurities, as defined above, that are of concern for human or animal health and/or the environment
Zgoraj opredeljene nečistoče, pogojno nevarne za zdravje ljudi ali živali in/ali okolje
On request the following samples must be provided:
Na zahtevo je treba predložiti vzorce:
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 iz opredelitve ostankov;
if available, samples of reference substances for the relevant impurities.
referenčnih snovi relevantnih nečistoč, kadar so na voljo.
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 proizvodov, in metode, s katerimi se dokaže, 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 tehnični snovi,
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 med shranjevanjem in roka uporabe mikroorganizma, kadar je primerno.
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, v živilih ter krmi, v živalskem in človeškem tkivu ter tekočinah, v tleh, v vodi (vključno s pitno vodo, podtalnico in površinskimi vodami) in zraku, kadar je ustrezno.
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 preskušanjem eksponentnih kultur in supernatantov kulture v živalskih celičnih bioloških testih.
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 povezanega z ravnanjem s fitofarmacevtskimi sredstvi, ki vsebujejo mikroorganizem, ali njihovo uporabo, in tveganja za ljudi, ki ravnajo s tretiranimi proizvodi, ter tveganja za ljudi zaradi sledov ostankov ali kontaminantov v živilih in vodi.
specify risk and safety phrases (once introduced) for the protection of man, animals and the environment to be included on packaging (containers),
natančno določitev opozorilnih in obvestilnih stavkov (ko so določeni) za zaščito ljudi, živali in okolja, ki morajo biti na embalaži (posodah),