natgillin/translations-raw huggingface dataset:
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 v smislu učinkovitosti in fitotoksičnosti/patogenosti fitofarmacevtskega sredstva za vsak posamezen način uporabe, naveden v zahtevku za registracijo.
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 preskusnih metod, je treba oceniti kakovost/metodologijo preskusov in naslednje značilnosti, če jih opisane metode vključujejo:
relevance; representativeness; sensitivity; specificity; reproducibility; interlaboratory validations; predictiveness.
ustreznost; 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.
Pri obrazložitvi rezultatov ocen države članice upoštevajo možne elemente nezanesljivosti informacij, pridobljenih med ocenjevanjem, s čimer se zagotovi, da se možnost neuspešnega odkrivanja škodljivih učinkov ali podcenjevanja njihove pomembnosti kar najbolj zmanjša.
The decision-making process shall be examined to identify critical decision points or items of data for which uncertainties could lead to a false classification of risk.
Preuči se postopek odločanja zaradi določitve kritičnih točk odločanja ali postavke podatkov, nezanesljivost katerih bi lahko povzročila napačno razvrstitev tveganja.
The first evaluation made shall be based on the best available data or estimates reflecting the realistic conditions of use of the plant protection product.
Prvo ocenjevanje se izvede na podlagi najprimernejših razpoložljivih podatkov ali ocen, ki izražajo dejanske pogoje uporabe fitofarmacevtskega sredstva.
This must 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.
Slediti mora ponovno ocenjevanje, pri katerem se upošteva potencialna nezanesljivost kritičnih podatkov in območje pogojev uporabe, ki bodo verjetno nastopili in katerih posledica bo pristop v realno najslabšem primeru, da se presodi, ali je mogoče, da je bila prva ocena bistveno drugačna.
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 fitofarmacevtsko sredstvo na osnovi mikroorganizmov, za katero je bil vložen zahtevek za registracijo v tej državi članici — upoštevajo se lahko informacije, ocenjene pri mikroorganizmu.
Member States must 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 morajo upoštevati, 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.
Pri ocenjevanju zahtevkov in pri odobritvi registracij države članice upoštevajo predlagane praktične pogoje uporabe in zlasti namen uporabe, odmerek, način nanašanja, pogostost in časovni razpored nanašanja ter vrsto in sestavo fitofarmacevtskega sredstva.
Whenever possible Member States shall also take into account the principles of integrated pest control.
Kadar koli je mogoče, države članice upoštevajo tudi načela integriranega varstva pred škodljivci.
In the evaluation, Member States shall consider the agricultural, plant health or environmental (including climatic) conditions in the areas of use.
Pri oceni države članice upoštevajo okoliščine kmetijske pridelave, zdravja 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, se:
make a best possible estimation of all relevant processes involved taking into account realistic parameters and assumptions,
po teh modelih izdela najboljša možna ocena vseh pomembnih vpletenih procesov, pri čemer se upoštevajo dejanski parametri in predpostavke;
be submitted to an evaluation as referred to in point 1.3.,
so ti modeli predmet ocene iz točke 1.3;
be reliably validated with measurements carried out under circumstances relevant for the use of the model,
se ti modeli verodostojno validirajo z meritvami, izvedenimi v razmerah, ustreznih za uporabo modela;
be relevant to the conditions in the area of use,
so ti modeli primerni glede na 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.
te modele spremljajo podrobnosti, ki prikazujejo, kako se po modelu izračunajo dobljene ocene, in obrazložitev vseh podatkov, vnesenih v model, ter podrobnosti, kako so bili dobljeni.
The data requirements, specified in Annex IIB and IIIB, 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 glede podatkov, opredeljene v prilogah IIB in IIIB, vsebujejo navodila, kdaj in kako je treba predložiti nekatere podatke, in postopke, po katerih je treba dokumentacijo pripraviti in oceniti.
That guidance must be respected.
Ta navodila je treba upoštevati.
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:
Pri oceni podatkov in informacij, priloženih zahtevkom, brez poseganja v splošna načela iz oddelka 1, države članice izvajajo naslednja načela:
The identity of the micro-organism should be clearly established.
Identiteta mikroorganizma mora biti jasno ugotovljena.
It must 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.
Zagotoviti je treba predložitev vseh ustreznih podatkov, ki bodo omogočali preverjanje identitete mikroorganizma v fitofarmacevtskem sredstvu na ravni soja.
The identity of the micro-organism shall be evaluated on the strain level.
Identiteta mikroorganizma se ovrednoti na ravni soja.
Where the micro-organism is either a mutant or a genetically modified organism, the specific differences from other strains within the same species must be recorded.
Če je mikroorganizem mutant ali gensko spremenjen organizem, je treba navesti posamične razlike med soji iste vrste.
Occurrence of resting stages must be recorded.
Navesti je treba pojav faz mirovanja.
The deposition of the strain at an internationally recognised culture collection must be checked.
Preveriti je treba, ali je soj 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 navzočem mikroorganizmu (glej zgoraj), pomembnih metabolitih/toksinih, ostankih rastnega gojišča, pomožnih snoveh v formulaciji in mikrobioloških onesnaževalcih.
Biological, physical, chemical, and technical properties
Biološke, fizikalne, kemijske in tehnične lastnosti
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 soja, kadar je ustrezno, njegov naravni habitat, vključno z navedbami ravni naravnega ozadja, življenjski cikel in možnosti za preživetje, kolonizacijo, razmnoževanje in razširjanje.
Proliferation of indigenous micro-organisms should after a short growth period level off and continue as for the background micro-organisms.
Rast in razmnoževanje avtohtonih mikroorganizmov se mora po kratkem obdobju rasti izravnati in nadaljevati kot pri mikroorganizmih naravnega ozadja.
The ability of micro-organisms to adapt to the environment must be evaluated.
Oceniti je treba sposobnost mikroorganizma za prilagajanje okolju.
In particular, Member States must take account of the following principles:
Države članice morajo upoštevati zlasti naslednja načela:
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 pogojev (npr. razpoložljivost substratov za rast in presnovo) mikroorganizmi lahko vzpostavijo ali prekinejo 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 soji mikroorganizmov lahko preživijo in se množijo bolje kakor neprilagojeni soji.
Adapted strains have a selective advantage and can form the majority within a population after a number of generations;
Prilagojeni soji imajo selektivno prednost in lahko po več rodovih tvorijo večino v populaciji;
the relatively rapid multiplication of micro-organisms leads to a higher frequency of mutations.
razmeroma hitro množenje mikroorganizmov je vzrok bolj pogostih 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 soj lahko postane prevladujoč;
the properties of viruses, in particular, can change rapidly, including their virulence.
zlasti hitro se lahko spremenijo lastnosti virusov, vključno z virulenco.
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 sposobnosti mikroorganizma za prenos genskega materiala na druge organizme in informacije o stabilnosti kodiranih lastnosti.
The mode of action of the micro-organism should be evaluated in as much detail as appropriate.
Ustrezno podrobno je treba oceniti način delovanja mikroorganizma.
The possible role of metabolites/toxins for the mode of action should be evaluated and when identified, the minimal effective concentration for each active metabolite/toxin should be established.
Oceniti je treba možno funkcijo metabolitov/toksinov pri načinu delovanja, po ugotovitvi funkcije pa določiti minimalno učinkovito koncentracijo pri vsakem aktivnem metabolitu/toksinu.
Information on mode of action can be a very valuable tool in identifying potential risks.
Informacije o načinu delovanja so lahko zelo dragoceno orodje pri določitvi možnega tveganja.
Aspects to be considered in the evaluation, are:
V postopku ocenjevanja 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,
sposobnost parazitiranja;
invertebrate pathogenicity.
patogenost nevretenčarjev.
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).
Da bi se ocenili možni učinki na neciljne organizme, je ob upoštevanju značilnosti in lastnosti iz (a) in (b) treba oceniti informacije o specifičnosti gostitelja mikroorganizma.
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 sposobnost 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 s poznanimi rastlinskimi, živalskimi ali človeškimi patogeni, ki so vrsta razreda aktivnih in/ali kontaminantnih mikroorganizmov.
Pathogenicity as well as virulence is strongly related to the host-species (e.g. determined by body temperature, physiological environment) and to the host conditions (e.g. health condition, immune status).
Patogenost in virulenca sta tesno povezani z vrsto gostitelja (ki ga določajo npr. telesna temperatura, fiziološko okolje) in stanjem gostitelja (npr. zdravstveno stanje, imunsko stanje).
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 sposobnosti 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 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, vdih, koža/rana) je lahko tudi kritični dejavnik.
For example, a microbial species may cause a disease following entry via skin damage, but not via the oral route.
Na primer, vrsta mikroorganizma lahko povzroči bolezen pri vstopu skozi poškodovano kožo, ne pa po oralni poti.
Many micro-organisms produce antibiosis substances that cause normal interferences in the microbial community.
Številni mikroorganizmi proizvajajo antibiozne 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 zoper antimikrobiološka sredstva, pomembna 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 antimikrobiološkim 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 vrsto 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 skladiščenju pripravka ob upoštevanju možnih sprememb v sestavi, npr. rast mikroorganizma ali mikroorganizmov onesnaževalcev, 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 ohranjanje teh značilnosti po skladiščenju, 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, navedene v tej specifikaciji;
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 pomembne fizikalne in kemijske lastnosti formulacije, navedene v Priročniku 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 je na predlagani oznaki zahtevana vključitev zahtev ali priporočil za uporabo pripravka v mešanici z drugimi fitofarmacevtskimi sredstvi ali dodatki in/ali kadar predlagana oznaka vključuje navedbe o združljivosti pripravka v mešanici z drugimi fitofarmacevtskimi sredstvi, 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, tj. prikazati je treba, da se vsako fitofarmacevtsko sredstvo v mešanici obnaša po pričakovanju in da ni nezdružljivosti.
The quality assurance criteria proposed for production of the micro-organism must be evaluated.
Oceniti je treba predlagana merila za zagotavljanje kakovosti pri produkciji mikroorganizma.
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.
Da se zagotovi dobra kakovost mikroorganizma, je treba upoštevati merila vrednotenja, ki se nanašajo na kontrolo postopka (izdelave), dobro proizvodno prakso, operativne prakse, potek procesa, čistilne postopke, spremljanje mikroorganizmov in higienske pogoje.
The quality, stability, purity etc., of the micro-organism must be addressed in the quality control system.
S sistemom kontrole kakovosti pa je treba nadzorovati kakovost, stabilnost, čistoto itn. mikroorganizma.
The quality assurance criteria proposed must be evaluated.
Oceniti je treba predlagana merila za zagotavljanje kakovosti.
Where the proposed use concerns the control of or protection against an organism, Member States shall evaluate the possibility that this organism could be harmful under the agricultural, plant health and environmental (including climatic) conditions in the area of the proposed use.
Kadar predlagana uporaba zadeva nadzor ali varstvo pred nekim organizmom, države članice ocenijo možnost, da bi bil ta organizem lahko škodljiv v okoliščinah kmetijske pridelave, zdravja rastlin in okolja (vključno s podnebnimi razmerami) na območju predlagane uporabe.
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 okoliščinah kmetijske pridelave, zdravja rastlin in okolja (vključno s podnebnimi razmerami), če se fitofarmacevtsko sredstvo ne bi uporabilo.
Member States shall evaluate the efficacy data provided for in Annex IIIB 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 podatke o učinkovitosti fitofarmacevtskega sredstva, določene v Prilogi IIIB, ob upoštevanju stopnje varstva rastlin ali obsega želenega učinka in ustreznih poskusnih pogojev, kakršni so:
the choice of the crop or cultivar,
izbira kulture ali sorte;
the agricultural and environmental (including climatic) conditions (if necessary for acceptable efficacy such data/information should also be given for the time before and after application),
kmetijske in okoljske (vključno podnebne) razmere (po potrebi je treba za priporočeno učinkovitost te podatke/informacije predložiti tudi za čas pred nanašanjem in po njem);
the presence and density of the harmful organism,
navzočnost in gostota škodljivega organizma;
the development stage of crop and organism,
razvojna stopnja kulture in škodljivega organizma;
the amount of the microbial plant protection product used,
količina uporabljenega fitofarmacevtskega sredstva na osnovi mikroorganizmov;
if required on the label, the amount of adjuvant added,
količina dodatka, če se zahteva na oznaki;
the frequency and timing of the applications,
pogostost in časovni razpored nanašanja;
the type of application equipment,
vrsta opreme za nanašanje;
the need for any special cleaning measures for the application equipment.
če so potrebni kakršni koli posebni ukrepi pri čiščenju opreme za nanašanje.
Member States shall evaluate the performance of the plant protection product under the range of agricultural, plant health and environmental (including climatic) conditions likely to be encountered in practice in the area of proposed use.
Države članice ocenijo delovanje fitofarmacevtskega sredstva v različnih okoliščinah kmetijske pridelave, zdravja rastlin in okolja (vključno s podnebnimi razmerami), ki so verjetni v praksi na območju predlagane uporabe.
The effect on integrated control must be included in the evaluation.
V oceno je treba vključiti učinek na integrirano varstvo.
In particular, consideration should be paid to:
Preučiti bi bilo treba zlasti:
the level, consistency and duration of the effect sought in relation to the dose in comparison with a suitable reference product or products, where they exist, and an untreated control;
stopnjo, doslednost in trajanje želenega vpliva glede na odmerek v primerjavi z ustreznim referenčnim sredstvom ali sredstvi (če obstajajo) ter kontrolo netretiranih rastlin;
where relevant, the effect on yield or reduction of loss in storage, in terms of quantity and/or quality, in comparison with a suitable reference product or products, where they exist, and an untreated control.
kadar je ustrezno, vpliv na pridelek ali zmanjšanje izgub pri skladiščenju v smislu količine in/ali kakovosti v primerjavi z ustreznim referenčnim sredstvom ali sredstvi (kadar obstajajo) in kontrolo netretiranih rastlin.