natgillin/translations-raw huggingface dataset:
If to the opinion of the applicant the trials from the first season adequately confirm the validity of claims made on the basis of extrapolation of results from other crops, commodities or situations or from tests with closely similar preparations, a justification, which is acceptable to the competent authority for not carrying out a second season's work must be provided.
Če se po mnenju vlagatelja s poskusi za prvo sezono primerno potrdi veljavnost trditev na podlagi ekstrapolacije rezultatov iz drugih kultur, proizvodov ali okoliščin ali na podlagi preskusov z zelo podobnimi pripravki, je treba predložiti utemeljitev za neizvajanje preskusov tudi v drugi sezoni, ki je sprejemljiva za pristojni organ.
Reports in summary form of preliminary tests, including glasshouse and field studies, used to assess the biological activity and dose range finding of the plant protection product and of the active substance(s) it contains, must be submitted when requested by the competent authority.
Na zahtevo pristojnega organa je treba predložiti poročila v obliki povzetka o predhodnih preskusih, vključno s študijami v steklenjakih in na prostem, za oceno biološke aktivnosti ter velikosti odmerka fitofarmacevtskega sredstva in aktivnih snovi, ki jih ta vsebuje.
These reports will provide additional information for the competent authority when it evaluates the plant production product.
V teh poročilih bodo navedene dodatne informacije, ki jih bo pristojni organ uporabil pri oceni fitofarmacevtskega sredstva.
Where this information is not submitted a justification which is acceptable to the competent authority must be provided.
Če ti podatki ne bodo predloženi, je treba navesti utemeljitev, ki bo sprejemljiva za pristojni organ.
Aim of the tests
Namen preskušanja
Normally a trial consists of three components:
Običajno poskus sestavljajo trije elementi:
The performance of the plant protection product must be investigated in relation to suitable reference products, where they exist.
Delovanje fitofarmacevtskega sredstva je treba preučiti glede na ustrezna referenčna sredstva, kadar ta obstajajo.
A suitable reference product is defined as an authorised plant protection product which has proved a sufficient performance in practice under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use.
Ustrezno referenčno sredstvo pomeni registrirano fitofarmacevtsko sredstvo, pri čemer je bilo v praksi dokazano njegovo zadovoljivo delovanje v razmerah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami) na področju predlagane uporabe.
In general, formulation type, effects on the harmful organisms, working spectrum and method of application shall be close to those of the tested plant protection product.
Na splošno so vrsta formulacije, učinki na škodljive organizme, območje delovanja in metoda nanašanja podobni kot pri preskušenem fitofarmacevtskem sredstvu.
Plant protection products must be tested in circumstances where the target harmful organism has been shown to have been present at a level causing or known to cause adverse effects (yield, quality, operational benefit) on an unprotected crop or area or on plants or plant products which have not been treated or where the harmful organism is present at such a level that an evaluation of the plant protection product can be made.
Fitofarmacevtska sredstva je treba preskusiti v okoliščinah, v katerih se ciljni škodljivi organizem pojavi v tolikšni meri, da povzroča ali lahko povzroči škodljive učinke (donos, kakovost, dobiček) na nevarovanih kulturah ali območju ali na netretiranih rastlinah ali rastlinskih proizvodih, ali v katerih je škodljivi organizem prisoten v tolikšni meri, da je mogoče izvesti oceno fitofarmacevtskega sredstva.
Trials to provide data on plant protection products for control of harmful organisms must show the level of control of the species of harmful organisms concerned or of species representative of groups for which claims are made.
S poskusi za pridobitev podatkov o fitofarmacevtskih sredstvih za zatiranje škodljivih organizmov je treba dokazati stopnjo delovanja na zadevne vrste škodljivih organizmov ali predstavnike vrst v skupini, za zatiranje katerih je sredstvo namenjeno.
Trials must include the different stages of growth of life cycle of the harmful species, where this is relevant and the different strains or races, where these are likely to show different degrees of susceptibility.
Poskuse je treba izvajati na različnih stopnjah razvoja življenjskega cikla škodljivih organizmov, kadar je to relevantno, in na različnih sevih ali rasah, če so predvidene različne stopnje občutljivosti.
Similarly, trials to provide data on plant protection products which are plant growth regulators, must show the level of effects on the species to be treated, and include investigation of differences in the response of a representative sample of the range of cultivars on which its use is proposed.
Podobno je treba s poskusi za pridobitev podatkov o fitofarmacevtskih sredstvih, ki so regulatorji rasti rastlin, dokazati stopnjo učinka na vrste, ki se tretirajo, pri čemer morajo ti preskusi vključevati preučevanje razlik v odzivu reprezentativnega vzorca različnih kultivarjev, za katere je predvidena uporaba sredstva.
In order to clarify the dose response, dose rates lower than the recommended one must be included in some trials in order to enable to assess whether the recommended rate is the minimum necessary to achieve the desired effect.
Za pojasnitev učinkovanja odmerka se pri nekaterih poskusih uporabijo nižji odmerki od priporočenih, da se lahko oceni, ali je priporočeni odmerek dejansko najmanjši odmerek, ki je potreben za doseganje želenega učinka.
The duration of the effects of treatment must be investigated in relation to the control of the target organism or effect on the treated plants or plant products, as appropriate.
Preučiti je treba trajanje učinkov tretiranja v zvezi z zatiranjem ciljnega organizma ali učinka na tretirane rastline ali rastlinske proizvode, če je to primerno.
When more than one application is recommended, trials must be reported which establish the duration of the effects of an application, the number of applications necessary and the desired intervals between them.
Kadar se priporoča več kot en nanos, je treba navesti poskuse, s katerimi se določijo trajanje učinkov nanosa, število potrebnih nanosov in potrebni presledki med njimi.
Evidence must be submitted to show that the dose, timing and method of application recommended give adequate control, protection or have the intended effect in the range of circumstances likely to be encountered in practical use.
Predložiti je treba dokaze, da priporočeni odmerek, čas nanosa in metoda nanašanja omogočajo ustrezno zatiranje, varstvo ali imajo želeni učinek v vseh okoliščinah, ki lahko nastanejo pri praktični uporabi.
Unless there are clear indications that the performance of the plant protection product is unlikely to be affected to a significant degree by environmental factors, such as temperature or rain, an investigation of the effects of such factors on performance must be carried out and reported, particularly where it is known that the performance of chemically related products is so affected.
Razen če obstajajo jasni dokazi, da okoljski dejavniki, kot je temperatura ali dež, verjetno ne vplivajo na delovanje fitofarmacevtskega sredstva, je treba izvesti in navesti preiskavo učinka takih dejavnikov na delovanje, zlasti če je znano, da vplivajo na delovanje kemijsko sorodnih sredstev.
Where proposed label claims include recommendations for the use of the plant protection product with other plant protection product(s) or adjuvant(s) information on the performance of the mixture must be provided.
Kadar so na predlagani oznaki proizvoda navedena priporočila za uporabo fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi ali pomožnimi sredstvi, je treba navesti informacije o delovanju mešanice.
Trials must be designed to investigate specified issues, to minimise the effects of random variation between different parts of each site and to enable statistical analysis to be applied to results amenable to such analysis.
Cilj poskusov mora biti preučevanje natančno določenih vprašanj, čim bolj omejiti učinke naključnih razlik med različnimi deli posamezne lokacije in omogočiti, da se za dobljene rezultate lahko uporabi statistična analiza.
The design, analysis and reporting of trials must be in accordance with European and Mediterranean Plant Protection Organisation (EPPO) guidelines 152 and 181.
Načrtovanje in analiza poskusov ter poročanje o njih morajo biti skladni s smernicama 152 in 181 Evropske in sredozemske organizacije za varstvo rastlin (EPPO).
The trials must be carried out in accordance to specific EPPO guidelines, where available, or with guidelines satisfying at least the requirements of the corresponding EPPO guideline.
Poskuse je treba izvajati v skladu s posebnimi smernicami EPPO, kadar so te na voljo, ali s smernicami, ki izpolnjujejo vsaj zahteve iz ustrezne smernice EPPO.
A statistical analysis of results amenable to such analysis must be carried out;
Izvesti je treba statistično analizo rezultatov, ki se lahko obdelajo s tako analizo;
where necessary the test guideline used must be adapted to enable such analysis.
po potrebi je treba prilagoditi smernice za preskušanje, da se omogoči izvedba take analize.
Laboratory data and where it exists, field information relating to the occurrence and development of resistance or cross-resistance in populations of harmful organisms to the active substance(s), or to related active substances, must be provided.
Zagotoviti je treba laboratorijske podatke in, kadar obstajajo, podatke s terena glede pojava in razvoja odpornosti ali navzkrižne odpornosti populacije škodljivih organizmov na aktivne snovi ali na sorodne aktivne snovi.
Where such information is not directly relevant to the uses for which authorisation is sought or to be renewed (different species of harmful organism or different crops), it must, if available, nevertheless be provided, as it may provide an indication of the likelihood of resistance developing in the target population.
Kadar se taki podatki ne nanašajo neposredno na vrste uporabe, za katere se zahteva registracija ali podaljšanje registracije (različne vrste škodljivih organizmov ali različne kulture), jih je treba kljub temu zagotoviti, če so na voljo, ker se lahko na podlagi teh informacij ugotovi verjetnost razvoja odpornosti pri ciljni populaciji.
Where there is evidence or information to suggest that, in commercial use, the development of resistance is likely, evidence must be generated and submitted as to the sensitivity of the population of the harmful organism concerned to the plant protection product.
Če obstajajo dokazi ali informacije, ki kažejo, da obstaja možnost razvoja odpornosti pri komercialni uporabi, je treba pridobiti in predložiti dokaze glede občutljivosti populacije zadevnih škodljivih organizmov na fitofarmacevtsko sredstvo.
In such cases a management strategy designed to minimise the likelihood of resistance or cross-resistance developing in target species must be provided.
V takih primerih je treba zagotoviti strategijo ravnanja za zmanjšanje verjetnosti razvoja odpornosti ali navzkrižne odpornosti pri ciljnih vrstah.
The tests shall provide sufficient data to permit an evaluation of the possible occurrence of taint or odour or other quality aspects of plants or plant products after treatment with the plant protection product.
S preskusi se zagotovi dovolj podatkov za oceno možnega pojava priokusa ali vonja ali drugih kakovostnih vidikov rastlin ali rastlinskih proizvodov po tretiranju s fitofarmacevtskim sredstvom.
The possibility of the occurrence of taint or odour in food crops must be investigated and be reported where:
Preučiti in navesti je treba verjetnost pojava priokusa ali vonja pri kulturah, namenjenih prehrani, kadar:
other products based on the same or a closely similar active ingredient have been shown to present a risk of occurrence of taint or odour.
se je pri drugih sredstvih na osnovi enakih ali zelo podobnih aktivnih snovi pokazalo, da predstavljajo nevarnost pojava priokusa ali vonja.
The effects of plant protection products on other quality aspects of treated plants or plant products must be investigated and reported where:
Preučiti in navesti je treba učinke fitofarmacevtskih sredstev na druge kakovostne vidike tretiranih rastlin ali rastlinskih proizvodov, kadar:
the nature of the plant protection product or it use could have an adverse influence on other quality aspects (for example in the case of use of plant growth regulators close to the harvest), or
bi lahko oblika fitofarmacevtskega sredstva ali njegova uporaba imela škodljiv vpliv na druge kakovostne vidike (na primer pri uporabi regulatorja rasti rastlin tik pred spravilom);
other products based on the same or a closely similar active ingredient have been shown to have an adverse influence on the quality.
ali se je pri drugih sredstvih na osnovi enakih ali zelo podobnih aktivnih snovi pokazalo, da imajo škodljiv vpliv na kakovost.
Testing shall be conducted initially on the main crops on which the plant protection product is to be used, at twice the normal rates of application and using, where relevant, the main methods of processing.
Na začetku se preskušanje izvaja na glavnih kulturah, na katerih se bo fitofarmacevtsko sredstvo uporabljalo, z dvakratnim običajnim odmerkom in ob uporabi, kadar je ustrezno, glavnih načinov predelave.
Where effects are observed it is necessary to perform testing at the normal rate of application.
Kadar se opazijo učinki, je treba izvesti preskušanje pri uporabi običajnega odmerka.
The extent of investigation necessary on other crops will depend on their degree of similarity of the main crops already tested, the quantity and quality of data available on those main crops and how far the manner of use of the plant protection product and methods of processing the crops, are similar.
Potreben obseg raziskav na drugih kulturah je odvisen od njihove podobnosti z že preskušenimi glavnimi kulturami, od količine in kakovosti razpoložljivih podatkov o navedenih glavnih kulturah ter od podobnosti načina uporabe fitofarmacevtskega sredstva in načina predelave kultur.
It is generally sufficient to perform the test with the main formulation type to be authorised.
Običajno zadostuje izvedba preskusa z glavno vrsto formulacije, ki je v postopku registracije.
The tests shall provide sufficient data to permit an evaluation of the possible occurrence of adverse effects after treatment with the plant protection product on transformation processes or on the quality of their products.
S preskusi se zagotovi dovolj podatkov za oceno možnega pojava škodljivih učinkov po tretiranju s fitofarmacevtskim sredstvom na postopke transformacije ali na kakovost proizvodov iz teh postopkov.
When the treated plants or plant products are normally intended for use in transformation process such as wine making, brewing or bread making and when at harvest significant residues are present, the possibility of the occurrence of adverse effects must be investigated and reported where:
Kadar so tretirane rastline ali rastlinski proizvodi običajno namenjeni uporabi v postopkih transformacije, kot je pridelava vina, proizvodnja piva ali priprava kruha, in če so ob spravilu prisotne znatne količine ostankov, je treba preučiti ter navesti možnost pojava škodljivih učinkov, kadar:
there are indications that the use of the plant protection product could have an influence on the processes involved (for example in the case of use of plant growth regulators or fungicides close to the harvest), or
obstajajo znaki, da bi uporaba fitofarmacevtskega sredstva lahko vplivala na te postopke (na primer pri uporabi regulatorjev rasti rastlin ali fungicidov tik pred spravilom), ali
other products based on the same or a closely similar active ingredient have been shown to have an adverse influence on these processes or its products.
se je pri drugih sredstvih na osnovi enakih ali zelo podobnih aktivnih snovi pokazalo, da imajo škodljiv učinek na te postopke ali proizvode.
The effects of plant protection products on the yield or yield components of treated plant products must be determined where relevant.
Kadar je ustrezno, je treba določiti učinke fitofarmacevtskih sredstev na donos ali elemente donosa tretiranih rastlinskih proizvodov.
When treated plants or plant products are likely to be stored the effect on the yield after storage, including data on storage life must be determined where relevant.
Če je verjetno, da se bodo tretirane rastline ali rastlinski proizvodi skladiščili, je treba določiti učinek na donos po skladiščenju, vključno s podatki o roku uporabe, kadar je ustrezno.
This information will normally be available from the tests required under the provisions of point 6.2.
Te informacije so običajno na voljo na podlagi preskusov, ki jih je treba izvesti v skladu z določbami točke 6.2.
For herbicides and for other plant protection products for which adverse effects, however transitory, are seen during the trials, performed in accordance with point 6.2, the margins of selectivity on target crops must be established, using twice the recommended rate of application.
Za herbicide in druga fitofarmacevtska sredstva, pri katerih se med izvajanjem poskusov v skladu s točko 6.2 ugotovijo škodljivi učinki, čeprav prehodni, je treba pri določitvi mej selektivnosti na ciljnih kulturah uporabiti dvakrat višji odmerek od priporočenega.
Where serious phytotoxic effects are seen, an intermediate application rate must also be investigated.
Če se ugotovijo resni fitotoksični učinki, je treba preučiti tudi vmesni odmerek.
If necessary, yield measurement must be submitted.
Po potrebi je treba predložiti meritve donosa.
The safety of a plant protection product to the main cultivars of the main crops for which it is recommended must be demonstrated, including effects of crop growth stage, vigour, and other factors which may influence susceptibility to damage or injury.
Dokazati je treba varnost fitofarmacevtskega sredstva za glavne kultivarje glavnih kultur, za katere se njegova uporaba priporoča, vključno z učinkom na posamezne stopnje rasti kulture, vitalnost in druge dejavnike, ki lahko vplivajo na občutljivost za poškodbe.
The extent of investigation necessary on other crops will depend on their degree of similarity to the main crops already tested, the quantity and quality of data available on those main crops and how far the manner of use of the plant protection product, if relevant, is similar.
Potreben obseg raziskav na drugih kulturah je odvisen od podobnosti z že preskušenimi glavnimi kulturami, količine in kakovosti razpoložljivih podatkov o zadevnih glavnih kulturah ter od podobnosti načina uporabe fitofarmacevtskega sredstva, če je to ustrezno.
Where proposed label claims include recommendations for the use of the plant protection product with other plant protection product(s), the previous paragraphs apply for the mixture.
Kadar so na predlagani oznaki proizvoda navedena priporočila za uporabo fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi, se za mešanico uporabijo prejšnji odstavki.
Observations concerning phytotoxicity must be performed in the tests provided for in point 6.2.
Opazovanja glede fitotoksičnosti je treba izvesti med preskušanjem iz točke 6.2.
Where phytotoxic effects are seen, they must be accurately assessed and recorded in accordance with EPPO guideline 135 or when a Member State requires so and when the test is carried out on the territory of this Member State, with guidelines satisfying at least the requirements of this EPPO guideline.
Če se ugotovijo fitotoksični učinki, jih je treba pravilno oceniti in zabeležiti v skladu s smernico 135 EPPO ali kadar to zahteva država članica in kadar se preskus izvaja na ozemlju zadevne države članice, s smernicami, ki izpolnjujejo vsaj zahteve te smernice EPPO.
A statistical analysis of results amenable to such analysis must be carried out, where necessary the test guideline used must be adapted to enable such analysis.
Izvesti je treba statistično analizo rezultatov, ki se lahko obdelajo s tako analizo, pri čemer je treba po potrebi prilagoditi uporabljeno smernico za preskušanje, da se omogoči taka analiza.
Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on succeeding crops.
Predloženih mora biti dovolj podatkov, da se lahko ocenijo morebitni škodljivi učinki tretiranja s fitofarmacevtskim sredstvom na naslednje kulture.
Where data, generated in accordance with point 9.1, shows that significant residues of the active substance, its metabolites or degradation products, which have or may have biological activity on succeeding crops, remain in soil or in plant materials, such as straw or organic material up to sowing or planting time of possible succeeding crops, observations must be submitted on effects on the normal range of succeeding crops.
Kadar podatki, pridobljeni v skladu s točko 9.1, kažejo, da znatna količina ostankov aktivne snovi, njenih metabolitov ali razgradnih produktov, ki biološko delujejo ali bi lahko delovali na naslednje kulture, ostane v tleh ali rastlinskem materialu, kot je slama, ali organskem materialu do časa setve ali sajenja morebitnih naslednjih kultur, je treba predložiti opažanja o učinku na običajen obseg naslednjih kultur.
Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on other plants, including adjacent crops.
Predložiti je treba dovolj podatkov, da je mogoče oceniti morebitne škodljive učinke tretiranja s fitofarmacevtskim sredstvom na druge rastline, vključno s sosednjimi kulturami.
Observations must be submitted on adverse effects on other plants, including the normal range of adjacent crops, when there are indications that the plant protection product could affect these plants via vapour drift.
Predložiti je treba opažanja o škodljivih učinkih na druge rastline, vključno z običajnim obsegom sosednjih kultur, če obstajajo dokazi, da bi lahko fitofarmacevtsko sredstvo vplivalo na te rastline zaradi zanašanja.
Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on plants or plant products to be used for propagation.
Predložiti je treba dovolj podatkov, da se lahko ocenijo morebitni škodljivi učinki tretiranja s fitofarmacevtskim sredstvom na rastline ali rastlinske proizvode, ki se uporabljajo za razmnoževanje.
for seeds — viability, germination and vigour;
za semena – sposobnost preživetja, kaljivost in vitalnost;
Seeds testing shall be done in accordance with ISTA Methods.
Preskušanje semen se izvede v skladu z metodami ISTA.
Any observed environmental effects must also be reported, especially effects on wildlife and/or beneficial organisms.
Navesti je treba tudi vse ugotovljene učinke na okolje, zlasti učinke na prostoživeče živali in rastline in/ali na koristne organizme.
A summary of all data and information provided under points 6.1 to 6.6 must be provided, together with a detailed and a critical assessment of the data, with particular reference to the benefits that the plant protection product offers, adverse effects that do or may arise and measures necessary to avoid or minimise adverse effects.
Predložiti je treba povzetek vseh podatkov in informacij iz točk 6.1 do 6.6, vključno s podrobno in kritično oceno navedenih podatkov, pri čemer je treba obravnavati zlasti koristne učinke fitofarmacevtskega sredstva, škodljive učinke, ki nastanejo ali bi lahko nastali, ter potrebne ukrepe za preprečitev ali čim učinkovitejše zmanjšanje škodljivih učinkov.
For proper evaluation of the toxicity including potential for pathogenicity and infectiveness of preparations sufficient information shall be available on acute toxicity, irritation and sensitisation of the micro-organism.
Za pravilno oceno toksičnosti pripravkov, vključno z možnostjo njihove patogenosti in kužnosti, je na voljo dovolj informacij o akutni toksičnosti, draženju in preobčutljivosti mikroorganizma.