natgillin/translations-raw huggingface dataset:
Special attention shall be given to co-formulants.
Posebna pozornost se nameni dodatkom.
While performing toxicology studies, all signs of infection or pathogenicity shall be noted.
Med izvajanjem toksikoloških študij se navedejo vsi znaki okužbe ali patogenosti.
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 bistveno, da se za vsako študijo zagotovi podroben opis (specifikacija) uporabljene snovi.
Tests must be conducted using the plant protection product to be authorised.
Pri izvajanju preskusov je treba uporabiti fitofarmacevtsko sredstvo, ki je v postopku registracije.
In particular, it must be clear that the micro-organism used in the preparation, and the conditions of culturing it, are the same for which information and data are submitted in the context of Part B of the Annex to Regulation (EU) No 283/2013.
Zlasti mora biti razvidno, da so mikroorganizem v pripravku in pogoji njegovega gojenja enaki, o čemer je treba predložiti informacije ter podatke v okviru dela B Priloge k Uredbi (EU) št. 283/2013.
A tiered testing system will be applied to the study of the plant protection product.
V študiji o fitofarmacevtskem sredstvu se bo uporabljal večstopenjski sistem preskušanja.
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, and in particular to establish, or indicate:
Študije, podatki in informacije, ki jih je treba predložiti ter oceniti, morajo zadoščati za opredelitev učinkov po enkratni izpostavljenosti fitofarmacevtskemu sredstvu, zlasti pa za določanje ali navedbo:
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 vsemi podrobnostmi o vedenjskih spremembah in možnih makroskopskih patoloških ugotovitvah pri obdukciji,
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.
Poudarek mora biti na oceni razponov toksičnosti, pridobljene informacije pa morajo omogočati tudi razvrstitev fitofarmacevtskega sredstva v skladu z Direktivo 1999/45/ES ali Uredbo (ES) št. 1272/2008.
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.
Preskus 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.
The test must be carried out in accordance with Method B.1 bis or B.1 tris of Regulation (EC) No 440/2008.
Preskus je treba izvesti v skladu z metodo B.1 bis ali B.1 tris Uredbe (ES) št. 440/2008.
The test will provide the inhalation toxicity to rats of the plant protection product.
S preskusom se zagotovijo podatki o inhalacijski toksičnosti fitofarmacevtskega sredstva pri podganah.
The test must be carried out where the plant protection product:
Preskus je treba izvesti, če: se fitofarmacevtsko sredstvo uporablja z opremo za zamegljevanje,
is to be applied from aircraft in cases where inhalation exposure is relevant,
se bo fitofarmacevtsko sredstvo nanašalo z letala, kadar je inhalacijska izpostavljenost pomembna,
contains a volatile component at greater than 10 %.
fitofarmacevtsko sredstvo vsebuje več kot 10 % hlapljivih sestavin.
The test must be carried out in accordance with Method B.2 of Regulation (EC) No 440/2008.
Preskus je treba izvesti v skladu z metodo B.2 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.
Preskus akutne perkutane toksičnosti se izvede le, če vlagatelj ne more zadovoljivo utemeljiti alternativnega pristopa 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.
Preskus je treba izvesti v skladu z metodo B.3 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 preskusom se ugotovi možnost dražilnosti fitofarmacevtskega sredstva za kožo, vključno z možno reverzibilnostjo opaženih učinkov.
The skin irritancy of the plant protection product must always be determined, except where the co-formulants are not expected to be skin irritant or the micro-organism is shown not to be skin irritant or where it is likely, as indicated in the test guideline, that severe skin effects can be excluded.
Vedno je treba določiti dražilnost fitofarmacevtskega sredstva za kožo, razen kadar se ne pričakuje, da bi dodatki dražili kožo, ali je dokazano, da mikroorganizem ne draži kože, ali kadar najverjetneje ni možnosti za hude kožne reakcije, kakor je navedeno v smernicah za preskušanje.
The test must be carried out in accordance with Method B.4 of Regulation (EC) No 440/2008.
Preskus je treba izvesti 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 preskusom se ugotovi možnost draženja oči, ki ga povzroči fitofarmacevtsko sredstvo, vključno z možno reverzibilnostjo opaženih učinkov.
The eye irritancy of the plant protection product must be determined, where the co-formulants are suspected to be eye irritant, except where the micro-organism is eye irritant or where it is likely, as indicated in the test guideline, that severe effects on the eyes may be produced.
Vedno je treba določiti dražilnost fitofarmacevtskega sredstva, kadar obstaja možnost, da dodatki dražijo oči, razen če mikroorganizem draži oči, ali kadar obstaja možnost hudih poškodb oči, kakor je navedeno v smernicah za preskušanje.
The eye irritation must be determined in accordance with Method B.5 of Regulation (EC) No 440/2008.
Preskus draženja oči mora potekati v skladu z metodo B.5 Uredbe (ES) št. 440/2008.
The test will provide sufficient information to assess the potential of the plant protection product to provoke skin sensitisation reactions.
S preskusom se zagotovi dovolj informacij za oceno možnosti, ali fitofarmacevtsko sredstvo povzroča reakcije preobčutljivosti kože.
The test must be carried out where the co-formulants are suspected to have skin sensitising properties, except where the micro-organism(s) or the co-formulants are known to have skin sensitising properties.
Preskus se izvede vedno, kadar obstaja možnost, da bi dodatki povzročali preobčutljivost kože, razen če je znano, da mikroorganizmi ali dodatki povzročajo preobčutljivost kože.
The tests have to be carried out in accordance with Method B.6 of Regulation (EC) No 440/2008.
Preskuse je treba izvajati v skladu z metodo B.6 Uredbe (ES) št. 440/2008.
The risks for those in contact with plant protection products (operators, bystanders, workers), depend on the physical, chemical and toxicological properties of the plant protection product as well as the type of the product (undiluted/diluted), formulation type, and on the route, the degree and duration of exposure.
Tveganja za osebe, ki pridejo v stik s fitofarmacevtskimi sredstvi (izvajalce tretiranja, delavce, druge navzoče osebe), so odvisna od fizikalnih, kemijskih in toksikoloških lastnosti fitofarmacevtskega sredstva ter tudi vrste proizvoda (nerazredčenega/razredčenega), vrste formulacije ter načina, stopnje in trajanja izpostavljenosti.
Sufficient information and data must be generated and reported to permit an assessment of the extent of exposure to the plant protection product likely to occur under the proposed conditions of use.
Pridobiti in navesti je treba zadostne informacije ter podatke za oceno obsega verjetne izpostavljenosti fitofarmacevtskemu sredstvu pri predlaganih pogojih uporabe.
In the cases where there is particular concern on the possibility of dermal absorption based on the information for the micro-organism available in Section 5 of Part B of the Annex to Regulation (EU) No 283/2013, or from the information provided for the preparation in this Section, further dermal absorption data can be necessary.
Kadar obstaja možnost dermalne absorpcije na podlagi razpoložljivih informacij za mikroorganizem iz oddelka 5 dela B Priloge k Uredbi (EU) št. 283/2013 ali informacij, predloženih za pripravek v tem oddelku, so morda potrebni dodatni podatki o dermalni absorpciji.
Results from exposure monitoring during production or use of the product must be submitted.
Predložiti je treba rezultate spremljanja izpostavljenosti med proizvodnjo ali uporabo sredstva.
The abovementioned information and data must provide the basis for the selection of appropriate protective measures including personal protective equipment to be used by operators and workers and to be specified on the label.
Zgoraj navedene informacije in podatki morajo zagotavljati podlago za izbiro ustreznih zaščitnih ukrepov, vključno z osebno zaščitno opremo, ki jo uporabljajo izvajalci tretiranja in delavci ter morajo biti navedeni na oznaki.
Where relevant, the following information shall be submitted for each co-formulant:
Kadar je ustrezno, se za vsak dodatek predložijo naslednje informacije:
the registration number as referred to in Article 20(3) of Regulation (EC) No 1907/2006 [13],
registracijska številka iz člena 20(3) Uredbe (ES) št. 1907/2006
the study summaries included in the technical dossier as referred to in Article 10(a)(vi) of Regulation (EC) No 1907/2006, and
povzetki študije, vključeni v tehnično dokumentacijo iz člena 10(a)(vi) Uredbe (ES) št. 1907/2006, in
In certain cases it may be necessary to carry out the studies as referred to under points 7.1 to 7.2.3 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 do 7.2.3 za kombinacije fitofarmacevtskih sredstev, kadar so na oznaki sredstva navedene zahteve za uporabo fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi in/ali pomožnimi sredstvi v mešanici v rezervoarju 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.
Odločitve o potrebi po dodatnih študijah je treba sprejemati za vsak primer posebej, pri čemer se upoštevajo rezultati študij o akutni toksičnosti posameznih fitofarmacevtskih sredstev, možnost izpostavljenosti kombinaciji zadevnih sredstev in razpoložljive informacije ali praktične izkušnje z zadevnimi ali podobnimi sredstvi.
A summary of all data and information provided under paragraphs 7.1 through 7.5, must be submitted, and include a detailed and critical assessment of those data in the context of relevant evaluative and decision-making criteria and guidelines, with particular reference to the risks for man and animals that may or do arise, and the extent, quality and reliability of the database.
Predložiti je treba povzetek vseh podatkov in informacij iz odstavkov 7.1 do 7.5, vključno z natančno in kritično oceno navedenih podatkov, ki temelji na ustreznih merilih ter smernicah za ocenjevanje in odločanje, pri čemer je treba obravnavati zlasti možno ali dejansko tveganje za ljudi in živali ter obseg, kakovost in zanesljivost podatkovne zbirke.
The same provisions as detailed in Section 6 of Part B of the Annex to Regulation (EU) No 283/2013, apply;
Uporabljajo se določbe iz oddelka 6 dela B Priloge k Uredbi (EU) št. 283/2013;
the information required in accordance with this Section has to be provided unless it is possible to extrapolate the residue behaviour of the plant protection product on the basis of the data available for the micro-organism.
informacije, zahtevane v skladu s tem oddelkom, je treba predložiti, razen če je mogoče na podlagi razpoložljivih podatkov za mikroorganizem ekstrapolirati obnašanje ostankov fitofarmacevtskega sredstva.
The same provisions as detailed in Section 7 of Part B of the Annex to Regulation (EU) No 283/2013 apply;
Uporabljajo se določbe iz oddelka 7 dela B Priloge k Uredbi (EU) št. 283/2013;
the information required in accordance with this Section has to be provided unless it is possible to extrapolate the fate and behaviour of the plant protection product in the environment on the basis of the data available in Section 7 of Part B of the Annex to Regulation (EU) No 283/2013.
informacije, zahtevane v skladu s tem oddelkom, je treba predložiti, razen če je mogoče ekstrapolirati končno stanje in obnašanje fitofarmacevtskega sredstva v okolju na podlagi podatkov iz oddelka 7 dela B Priloge k Uredbi (EU) št. 283/2013.
The information provided, taken together with that for the micro-organism(s), must be sufficient to permit an assessment of the impact on non-target species (flora and fauna), of the plant protection product, when used as proposed.
Predložene informacije, skupaj z informacijami za mikroorganizme, morajo zadoščati za oceno vpliva fitofarmacevtskega sredstva na neciljne vrste (rastlinske in živalske vrste) ob predlagani uporabi.
Impact can result from single, prolonged or repeated exposure, and can be reversible, or irreversible.
Vpliv je lahko posledica enkratne, dolgotrajne ali večkratne izpostavljenosti, pri čemer je lahko reverzibilen ali nereverzibilen.
The choice of the appropriate non-target organisms for testing of environmental effects shall be based on the information on the micro-organism, as required in Part B of the Annex to Regulation (EU) No 283/2013, and on the information on the co-formulants and other components, as required by Sections 1 to 9 of this Annex.
Izbira primernih neciljnih organizmov za preskušanje učinkov na okolje temelji na informacijah o mikroorganizmu, kakor je zahtevano v delu B Priloge k Uredbi (EU) št. 283/2013, ter informacijah o dodatkih in drugih sestavinah, kakor je zahtevano v oddelkih 1 do 9 te priloge.
From such knowledge it would be possible to choose the appropriate test organisms, such as organisms closely related to the target organism.
Na podlagi teh ugotovitev bi bilo mogoče izbrati primerne preskusne organizme, kot so organizmi v ožjem sorodstvu s ciljnim organizmom.
In particular, the information provided for the plant protection product, together with other relevant information, and that provided for the micro-organism, shall be sufficient to:
Informacije v zvezi s fitofarmacevtskim sredstvom skupaj z drugimi pomembnimi informacijami in informacijami, predloženimi za mikroorganizem, zadoščajo zlasti za:
specify the hazard symbols, the indications of danger, and relevant risk and safety phrases or the pictograms, signal words, relevant hazard and precautionary statements, for the protection of the environment, to be mentioned on packaging (containers),
natančno določitev simbolov za nevarnost, oznak za nevarnost, ustreznih opozorilnih in obvestilnih stavkov ali piktogramov, opozorilnih besed ter ustreznih stavkov o nevarnosti in previdnostnih stavkov za varstvo okolja, ki morajo biti navedeni na embalaži (posodah),
permit an evaluation of the short- and long-term risks for non-target species — populations, communities, and processes as appropriate,
oceno kratkoročnih in dolgoročnih tveganj za neciljne vrste – populacije, skupnosti in procese, kot je primerno,
There is a need to report all potentially adverse effects found during routine investigations of environmental effects and to undertake and report such additional studies which may be necessary to investigate the mechanisms involved and assess the significance of these effects.
Navesti je treba vse morebitne škodljive učinke, ugotovljene med rutinskimi preučevanji učinkov na okolje, ter izvajati in navesti dodatne študije, ki so morda potrebne za preučitev mehanizmov v teh procesih in oceno pomena takšnih učinkov.
Where exposure data are necessary to decide whether a study has to be performed, the data obtained in accordance with Section 9 of Part B of this Annex, shall be used.
Kadar so podatki o izpostavljenosti potrebni za odločitev, ali je treba izvesti študijo, se uporabijo podatki, pridobljeni v skladu z oddelkom 9 dela B te priloge.
For the estimation of exposure of organisms all relevant information on the plant protection product and on the micro-organism must be taken into account.
Pri ocenjevanju izpostavljenosti organizmov je treba upoštevati vse pomembne informacije o fitofarmacevtskem sredstvu in mikroorganizmu.
Where relevant the parameters provided for in this Section shall be used.
Kadar je ustrezno, se uporabijo parametri iz tega oddelka.
Where it appears from available data that the plant protection product has a stronger effect than the micro-organism, the data on effects on non target organisms of the plant protection product have to be used for the calculation of relevant effect/exposure ratios.
Kadar je na podlagi razpoložljivih podatkov razvidno, da ima fitofarmacevtsko sredstvo močnejši učinek kot mikroorganizem, je treba za izračun ustreznih razmerij med učinkom in izpostavljenostjo uporabiti podatke o učinkih fitofarmacevtskega sredstva na neciljne organizme.
In order to facilitate the assessment of the significance of test results obtained, the same strain of each relevant species shall where possible be used in the various specified tests for effects on non target organisms.
Za lažjo oceno pomena pridobljenih rezultatov preskusov se, kadar je to mogoče, uporabi isti sev posameznih relevantnih vrst v različnih posebnih preskusih za učinke na neciljne organizme.
The same information as provided in point 8.1 of Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of birds is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti informacije iz točke 8.1 dela B Priloge k Uredbi (EU) št. 283/2013, razen če se lahko utemelji, da je izpostavljenost ptic malo verjetna.
The same information as provided in point 8.2 of Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of aquatic organisms is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti informacije iz točke 8.2 dela B Priloge k Uredbi (EU) št. 283/2013, razen če se lahko utemelji, da je izpostavljenost vodnih organizmov malo verjetna.
The same information as provided in point 8.3 of Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of bees is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti informacije iz točke 8.3 dela B Priloge k Uredbi (EU) št. 283/2013, razen če se lahko utemelji, da je izpostavljenost čebel malo verjetna.
The same information as provided in point 8.4 of Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of arthropods other than bees is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti informacije iz točke 8.4 dela B Priloge k Uredbi (EU) št. 283/2013, razen če se lahko utemelji, da je izpostavljenost členonožcev, razen čebel, malo verjetna.
The same information as provided in point 8.5 of Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of earthworms is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti informacije iz točke 8.5 dela B Priloge k Uredbi (EU) št. 283/2013, razen če se lahko utemelji, da je izpostavljenost deževnikov malo verjetna.
The same information as provided in point 8.6 Part B of the Annex to Regulation (EU) No 283/2013 has to be reported where it is not possible to predict the effects of the plant protection product on the basis of the data available for the micro-organism, unless it can be justified that exposure of non target soil micro-organisms is unlikely to occur.
Kadar učinkov fitofarmacevtskega sredstva ni mogoče predvideti na podlagi razpoložljivih podatkov za mikroorganizem, je treba navesti informacije iz točke 8.6 dela B Priloge k Uredbi (EU) št. 283/2013, razen če se lahko utemelji, da je izpostavljenost neciljnih talnih mikroorganizmov malo verjetna.
Such decision will take into consideration the available information in this and other Sections, in particular data on the specificity of the micro-organism, and the expected exposure.
Pri takšni odločitvi se upoštevajo razpoložljive informacije iz tega oddelka in drugih oddelkov, zlasti podatki o specifičnosti mikroorganizma, in pričakovana izpostavljenost.
Special attention shall be given to possible effects on naturally occurring and deliberately released organisms of importance in IPM.
Posebna pozornost se nameni morebitnim učinkom na naravno prisotne in namerno spuščene organizme, pomembne pri integriranem zatiranju škodljivcev.
In particular the compatibility of the product with IPM shall be taken into consideration.
Upošteva se zlasti skladnost sredstva z integriranim zatiranjem škodljivcev.
Additional studies might include further studies on additional species or higher tier studies such as studies on selected non-target organisms.
Dodatne študije lahko vključujejo nadaljnje študije na dodatnih vrstah ali študije na višji stopnji, kot so študije na izbranih neciljnih organizmih.
A summary and evaluation of all data relevant to the environmental impact shall be carried out in accordance with the guidance given by the competent authorities of the Member States concerning the format of such summaries and evaluations.
Povzetek in ocena vseh pomembnih podatkov o vplivu na okolje se pripravita v skladu s smernicami pristojnih organov držav članic v zvezi z obliko takšnih povzetkov in ocen.
It shall include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for the environment and non-target species that may or do arise, and the extent, quality and reliability of the database.
Povzetek vključuje podrobno in kritično oceno navedenih podatkov, ki temelji na ustreznih merilih ter smernicah za ocenjevanje in odločanje, pri čemer je treba obravnavati zlasti možno ali dejansko tveganje za okolje in neciljne vrste ter obseg, kakovost in zanesljivost podatkovne zbirke.