natgillin/translations-raw huggingface dataset:
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 v primeru uporabe rastnega regulatorja rastlin 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 the quality.
se je pri drugih sredstvih na podlagi 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 testiranje izvaja na glavnih kulturah, na katerih se bo fitofarmacevtsko sredstvo uporabljalo, z dvakratnim običajnim odmerkom in ob uporabi, kadar je to relevantno, glavnih oblik predelave.
Where effects are observed it is necessary to perform testing at the normal rate of application.
Če se učinki opazijo, je treba izvesti testiranje 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 testiranimi glavnimi kulturami, od količine in kakovosti razpoložljivih podatkov o navedenih glavnih kulturah in od tega, do kakšne mere sta način uporabe fitofarmacevtskega sredstva in metoda predelave kultur podobna.
It is generally sufficient to perform the test with the main formulation type to be authorised.
Običajno je dovolj izvesti test z glavno vrsto formulacije, ki je v postopku registracije.
Effects on transformation processes
Vplivi na postopke predelave
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.
Testi zagotovijo dovolj podatkov za oceno možnega pojava škodljivih učinkov po tretiranju s fitofarmacevtskim sredstvom na postopke predelave 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 predelave, kot so pridelava vina, piva ali priprava kruha, in če so ob spravilu prisotne znatne količine ostankov, je treba raziskati in 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 v primeru uporabe rastnih regulatorjev 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 podlagi enakih ali zelo podobnih aktivnih snovi pokazalo, da imajo škodljiv vpliv na te postopke ali na proizvode.
Effects on the yield of treated plants or plant products
Vplivi na pridelek tretiranih rastlin ali rastlinskih proizvodov
The test shall provide sufficient data to permit an evaluation of the performance of the plant protection product and of possible occurrence of yield reduction or loss in storage of treated plants or plant products.
Testi zagotovijo dovolj podatkov za oceno delovanja fitofarmacevtskega sredstva in možnega pojava zmanjšanja pridelka ali izgube pri skladiščenju tretiranih rastlin ali rastlinskih proizvodov.
The effects of plant protection products on the yield or yield components of treated plants or plant products must be determined where relevant.
Določiti je treba učinke fitofarmacevtskih sredstev na pridelek ali na elemente pridelka tretiranih rastlin ali rastlinskih proizvodov, kadar je to relevantno.
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 pridelek po skladiščenju, vključno s podatki o roku skladiščenja, kadar je to relevantno.
This information will normally be available from the tests required in point 6.2.
Te informacije so običajno na voljo iz testov, ki so obvezni v skladu s točko 6.2.
Phytotoxicity to target plants (including different cultivars), or to target plant products
Fitotoksičnost za ciljne rastline (vključno z različnimi kultivarji) ali za ciljne rastlinske proizvode
The test shall provide sufficient data to permit an evaluation of the performance of the plant protection product and of the possible occurrence of phytotoxicity after treatment with the plant protection product.
Testi zagotovijo dovolj podatkov za oceno delovanja fitofarmacevtskega sredstva in možnega pojava fitotoksičnosti po tretiranju s fitofarmacevtskim sredstvom.
For herbicides and for other plant protection products for which adverse effects, however transitory, are seen during the trials, performed in accordance to point 6.2, the margins of selectivity on target crops must be established, using twice the recommended rate of application.
Za herbicide in za druga fitofarmacevtska sredstva, pri katerih se med izvajanjem poskusov v skladu s točko 6.2 ugotovijo kakršni koli škodljivi učinki, čeprav prehodni, je treba določiti meje selektivnosti na ciljnih kulturah z dvakrat višjim odmerkom od priporočenega.
Where serious phytotoxic effects are seen, an intermediate application rate must also be investigated.
Kadar se ugotovijo resni fitotoksični učinki, je treba preučiti tudi vmesni odmerek.
Where adverse effects occur, but are claimed to be unimportant in comparison with the benefits of use or transient, evidence to support this claim is required.
Kadar pride do škodljivih učinkov, ki naj bi bili v primerjavi s koristnostjo uporabe nepomembni ali prehodni, treba dokazati to trditev.
If necessary yield measurement must be submitted.
Po potrebi je treba predložiti meritve pridelka.
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 priporoča, vključno z vplivom na posamezne stopnje rasti kulture, na vitalnost in na 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 testiranimi glavnimi kulturami, od količine in kakovosti razpoložljivih podatkov o navedenih glavnih kulturah in od tega, do kakšne mere je način uporabe fitofarmacevtskega sredstva podoben, če je to relevantno.
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 predlagana oznaka priporoča uporabo fitofarmacevtskega sredstva skupaj 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 testiranjem 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.
Kadar se ugotovijo fitotoksični učinki, jih je treba pravilno oceniti in zabeležiti v skladu s 135. smernicami EPPO ali, kadar to zahteva država članica in kadar se test izvaja na ozemlju 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; po potrebi je treba spremeniti smernice za testiranje, da se omogoči taka analiza.
Observations on undesirable or unintended side-effects, e.g. on beneficial and other non-target organisms, on succeeding crops, other plants or parts of treated plants used for propagating purposes (e.g. seeds, cuttings, runners)
Ugotavljanje neželenih ali nenamenskih stranskih učinkov, npr. na koristne in druge neciljne organizme, na naslednje kulture, na druge rastline ali dele tretiranih rastlin, namenjene za razmnoževanje (npr. seme, potaknjenci, sadike)
Impact on succeeding crops
Vpliv na naslednje kulture
Aim of the information required
Namen zahtevanih informacij
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 je mogoča ocena morebitnih škodljivih učinkov 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 vplivu na normalen obseg naslednjih kultur.
Impact on other plants, including adjacent crops
Vpliv na druge rastline, vključno s sosednjimi kulturami
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.
Predloženih mora biti dovolj podatkov, da je mogoča ocena morebitnih škodljivih učinkov 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 znaki, da bi fitofarmacevtsko sredstvo lahko vplivalo na te rastline zaradi zanašanja.
Impact on treated plants or plant products to be used for propagation
Vpliv na tretirane rastline ali rastlinske proizvode, ki se uporabljajo za razmnoževanje
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.
Predloženih mora biti dovolj podatkov, da je mogoča ocena morebitnih škodljivih učinkov tretiranja s fitofarmacevtskim sredstvom na rastline ali rastlinske proizvode, ki se uporabljajo za razmnoževanje.
Observations must be submitted on the impact of plant protection products on plant parts used for propagation except where the proposed uses preclude use on crops intended for production of seeds, cuttings, runners or tubers for planting, as appropriate.
Predložiti je treba opažanja o vplivu fitofarmacevtskih sredstev na dele rastlin, ki se uporabljajo za razmnoževanje, razen če predlagana uporaba izključuje uporabo na kulturah, namenjenih za proizvodnjo semena, potaknjencev, sadik ali gomoljev za sajenje.
for seeds — viability, germination and vigour;
za semena – sposobnost za preživetje, kaljivost in vitalnost;
for cuttings — rooting and growth rates;
za potaknjence – ukoreninjenje in hitrost rasti;
for runners — establishment and growth rates;
za sadike – začetek rasti in hitrost rasti;
for tubers — sprouting and normal growth.
za gomolje – kaljivost in običajna rast.
Seeds testing shall be done in accordance with ISTA Methods [10].6.6.4. Effects on beneficial and other non-target organisms
Testiranje semen se izvede v skladu z metodami ISTA [10].6.6.4 Vplivi na koristne in druge neciljne organizme
Any effects, positive or negative, on the incidence of other harmful organisms, observed in the tests performed in accordance with the requirements of this Section, shall be reported.
Poroča se o vsakem opaženem vplivu, pozitivnem ali negativnem, na pojavnost drugih škodljivih organizmov pri izvajanju testov v skladu z zahtevami tega oddelka.
Any observed environmental effects must also be reported, especially effects on wildlife and/or beneficial organisms.
Navesti je treba tudi vse opažene vplive na okolje, zlasti vpliv na prostoživeče živali in rastline in/ali na koristne organizme.
Summary and evaluation of data presented under 6.1 to 6.6
Povzetek in ocena podatkov iz točk 6.1 do 6.6
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, skupaj s podrobno in kritično oceno teh podatkov, s posebnim ozirom na koristne učinke fitofarmacevtskega sredstva, na škodljive učinke, ki nastanejo ali bi lahko nastali, in na potrebne ukrepe za preprečitev ali čim učinkovitejše zmanjšanje škodljivih učinkov.
For proper evaluation of the toxicity of preparations sufficient information shall be available on acute toxicity, irritation and sensitisation of the active substance.
Za pravilno oceno toksičnosti pripravkov je na voljo dovolj informacij o akutni toksičnosti, draženju in preobčutljivosti, ki jo povzroča aktivna snov.
If possible, additional information on mode of toxic action, toxicological profile and all other known toxicological aspects of the active substance shall be submitted.
Če je to mogoče, se predložijo dodatne informacije o načinu toksičnega delovanja, toksikoloških lastnostih in vseh drugih znanih toksikoloških vidikih aktivne snovi.
In the context of the influence that impurities and other components can have on toxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, be provided.
V zvezi z vplivom, ki ga lahko imajo nečistoče in druge sestavine na toksikološko obnašanje, je bistvenega pomena, da se za vsako študijo zagotovi podroben opis (specifikacija) uporabljene snovi.
Tests must be conducted using the plant protection product to be authorised.
Teste je treba izvajati ob uporabi fitofarmacevtskega sredstva, ki je v postopku registracije.
The studies, data and information to be provided and evaluated, must be sufficient to permit the identification of effects following a single exposure to the plant protection product, to be assessed, and in particular to establish, or indicate:
Študije, podatki in druge informacije, ki jih je treba predložiti in oceniti, morajo zadoščati za opredelitev učinkov po enkratni izpostavljenosti fitofarmacevtskemu sredstvu, in zlasti za določitev ali navedbo:
the toxicity of the plant protection products,
toksičnosti fitofarmacevtskih sredstev,
toxicity of the plant protection product relative to the active substance,
toksičnosti fitofarmacevtskega sredstva glede na aktivno snov,
the time course and characteristics of the effect with full details of behavioural changes and possible gross pathological findings at post-mortem,
časovnega poteka in značilnosti učinka z natančnimi podrobnostmi o spremembah v obnašanju in morebitnih makroskopskih patoloških ugotovitvah pri obdukciji,
where possible the mode of toxic action, and
načina toksičnega delovanja, kadar je to mogoče, in
While the emphasis must be on estimating the toxicity ranges involved, the information generated must also permit the plant protection product to be classified in accordance with Directive 1999/45/EC or Regulation (EC) No 1272/2008.
Medtem ko mora biti poudarek na ocenjevanju razponov toksičnosti v teh procesih, morajo pridobljene informacije omogočati tudi razvrščanje fitofarmacevtskega sredstva v skladu z Direktivo 1999/45/ES ali Uredbo (ES) št. 1272/2008.
The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations.
Informacije, pridobljene z izvajanjem testov akutne toksičnosti, so zlasti koristne pri ocenjevanju nevarnosti, ki se lahko pojavijo pri nesrečah.
An acute oral test shall always be carried only if the applicant cannot justify an alternative approach under Directive 1999/45/EC or Regulation (EC) No 1272/2008, where applicable.
Test akutne oralne toksičnosti se vedno izvede, razen če lahko vlagatelj zadovoljivo utemelji alternativni pristop v skladu z Direktivo 1999/45/ES ali Uredbo (ES) št. 1272/2008, kadar je to ustrezno.
Test method
Testna metoda
The test must be carried out in accordance with Method B 1 bis or B 1 tris of Regulation (EC) No 440/2008.
Test je treba izvajati v skladu z metodo B 1 bis ali B 1 tris Uredbe (ES) št. 440/2008.
An acute percutaneous test shall be conducted only if the applicant cannot justify an alternative approach under Directive 1999/45/EC or Regulation (EC) No 1272/2008, where applicable.
Test akutne perkutane toksičnosti se izvede, razen če lahko vlagatelj zadovoljivo utemelji alternativni pristop v skladu z Direktivo 1999/45/ES ali Uredbo (ES) št. 1272/2008, kadar je to ustrezno.
The test must be carried out in accordance with Method B 3 of Regulation (EC) No 440/2008.
Test je treba izvajati v skladu z metodo B 3 Uredbe (ES) št. 440/2008.
The test will provide the inhalation toxicity to rats of the plant protection product or of the smoke it generates.
S testom se določi inhalacijska toksičnost fitofarmacevtskega sredstva ali dima, ki se razvija iz njega, za podgane.
The test must be carried out where the plant protection product:
Test je treba izvesti, kadar: se fitofarmacevtsko sredstvo uporablja z opremo za zamegljevanje,
is used with fogging equipment,
se fitofarmacevtsko sredstvo uporablja z opremo za zamegljevanje,
is a vapour releasing preparation,
je fitofarmacevtsko sredstvo pripravek, ki sprošča paro,
is an aerosol,
je fitofarmacevtsko sredstvo aerosol,
is a powder containing a significant proportion of particles of diameter < 50 μm (> 1 % on a weight basis),
je fitofarmacevtsko sredstvo prašek z znatnim deležem delcev premera < 50 μm (> 1 mas. %),
is to be applied from aircraft in cases where inhalation exposure is relevant,
se bo fitofarmacevtsko sredstvo nanašalo z letala, kadar je inhalacijska izpostavljenost relevantna,
contains an active substance with a vapour pressure > 1 × 10–2 Pa and is to be used in enclosed spaces such as warehouses or glasshouses,
fitofarmacevtsko sredstvo vsebuje aktivno snov s parnim tlakom, večjim od 1 × 10–2 Pa, in je namenjeno uporabi v zavarovanih prostorih, kot so skladišča ali rastlinjaki,
is to be applied in a manner which generates a significant proportion of particles or droplets of diameter < 50 μm (> 1 % on a weight basis).
se bo fitofarmacevtsko sredstvo nanašalo na način, ki povzroča nastanek znatnega deleža delcev ali kapljic premera < 50 μm (> 1 mas. %).
The test must be carried out in accordance with Method B 2 of Regulation (EC) No 440/2008.
Test je treba izvajati v skladu z metodo B 2 Uredbe (ES) št. 440/2008.
The test will provide the potential of skin irritancy of the plant protection product including the potential reversibility of the effects observed.
S testom se ugotovi možnost draženja kože, ki ga povzroča fitofarmacevtsko sredstvo, vključno z možnostjo reverzibilnosti ugotovljenih učinkov.
The skin irritancy of the plant protection product must be determined except where it is likely, as indicated in the test guideline, that severe skin effects may be produced or that effects can be excluded.
Dražilnost kože fitofarmacevtskega sredstva je treba določiti, razen če obstaja, kot je navedeno v smernicah za testiranje, možnost hudih kožnih reakcij ali se učinki draženja kože lahko izključijo.
The test must be carried out in accordance with Method B 4 of Regulation (EC) No 440/2008.
Test je treba izvajati v skladu z metodo B 4 Uredbe (ES) št. 440/2008.
The test will provide the potential for eye irritation of the plant protection product, including the potential reversibility of the effects observed.
S testom se ugotovi možnost draženja oči, ki ga povzroči fitofarmacevtsko sredstvo, vključno z možnostjo reverzibilnosti ugotovljenih učinkov.
The eye irritation must be determined in accordance with Method B 5 of Regulation (EC) No 440/2008.
Določanje draženja oči mora potekati v skladu z metodo B 5 Uredbe (ES) št. 440/2008/EGS.
The test will provide sufficient information to assess the potential of the plant protection product to provoke skin sensitisation reactions.
Test zagotovi dovolj informacij za oceno možnosti, ali bo fitofarmacevtsko sredstvo povzročilo reakcije preobčutljivosti kože.
The tests must always be carried out except where the active substance(s) or co-formulants are known to have sensitising properties.
Testi so obvezni, razen kadar je že znano, da imajo aktivne snovi ali pomožne snovi v formulaciji lastnosti, ki povzročajo preobčutljivost kože.
The tests have to be carried out in accordance with Method B 6 of Regulation (EC) No 440/2008.
Teste je treba izvajati v skladu z metodo B 6 Uredbe (ES) št. 440/2008.
Supplementary studies for combinations of plant protection products
Dopolnilne študije za kombinacije fitofarmacevtskih sredstev
In certain cases it may be necessary to carry out the studies as referred to under points 7.1.1 to 7.1.6 for a combination of plant protection products where the product label includes requirements for use of the plant protection product with other plant protection products and/or with adjuvants as a tank mix.
V nekaterih primerih je morda treba izvesti študije iz točk 7.1.1 do 7.1.6 za mešanice fitofarmacevtskih sredstev, kadar oznaka proizvoda zahteva uporabo fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi in/ali pomožnimi sredstvi v mešanici v tanku škropilnice.
Decisions as to the need for supplementary studies must be made on a case by case basis, taking into account the results of the acute toxicity studies of the individual plant protection products, the possibility for exposure to the combination of the products concerned and available information or practical experience with the products concerned or similar products.
Odločitev o potrebnih dodatnih študijah je treba sprejeti za vsak posamezen primer, ob upoštevanju rezultatov študij o akutni toksičnosti posameznih fitofarmacevtskih sredstev, možnosti izpostavljenosti mešanici zadevnih sredstev in dostopnih informacij ali praktičnih izkušenj z zadevnimi ali podobnimi sredstvi.