natgillin/translations-raw huggingface dataset:
Intervals between the application of the plant protection product containing micro-organisms and chemical pesticides, or a list with active substances of chemical plant protection products not to be used together with the plant protection product containing micro-organisms on the same crop, shall also be provided.
Prav tako se navedejo časovni razmiki med uporabo fitofarmacevtskega sredstva z vsebnostjo mikroorganizmov in kemijskih pesticidov ali seznam aktivnih snovi kemijskih fitofarmacevtskih sredstev, ki se ne smejo uporabljati skupaj s fitofarmacevtskim sredstvom z vsebnostjo mikroorganizma na isti kulturi.
For each method of application and each use, the rate of application per unit (ha, m2, m3) treated, in terms of g or kg or l for the preparation and in terms of appropriate units for the micro-organism, must be provided.
Za vsako metodo nanosa in vsako uporabo je treba navesti odmerek na tretirano enoto (ha, m2, m3) v g ali kg ali l za pripravek in v ustreznih enotah za mikroorganizem.
Content of micro-organism in material used (e.g. in the diluted spray, baits or treated seed)
Vsebnost mikroorganizma v uporabljeni snovi (npr. razredčenem razpršilu, vabah ali tretiranemu semenu)
The content of micro-organism shall be reported, as appropriate, in number of active unit/ml or g or any other relevant unit.
Vsebnost mikroorganizma se izrazi, kot ustreza, s številom aktivnih enot/ml ali g ali z drugo ustrezno enoto.
Where possible and necessary the interval between applications, in days, must be stated.
Kadar je to mogoče in potrebno, je treba navesti časovne razmike med nanosi v dnevih.
Necessary waiting periods or other precautions to avoid phytopathogenic effects on succeeding crops
Potrebne karence ali drugi varnostni ukrepi za preprečevanje fitopatogenih učinkov na naslednjih kulturah
Where relevant, minimum waiting periods between last application and sowing or planting of succeeding crops, which are necessary to avoid phytopathogenic effects on succeeding crops, must be stated, and follow from the data provided under Section 6, point 6.6.
Kadar je to relevantno, je treba navesti najnujnejše karence med zadnjim nanosom in setvijo ali sajenjem naslednjih kultur, ki so potrebne za preprečevanje fitopatogenih učinkov na naslednje kulture in izhajajo iz podatkov iz točke 6.6 oddelka 6.
Packaging and compatibility of the preparation with proposed packaging materials
Embalaža in skladnost pripravka s predlaganimi materiali za pakiranje
The suitability of the packaging, including closures, in terms of its strength, leakproofness and resistance to normal transport and handling, must be determined and reported in accordance with ADR methods 3552, 3553, 3560, 3554, 3555, 3556, 3558, or appropriate ADR Methods for intermediate bulk containers, and, where for the preparation child-resistant closures are required, in accordance with ISO standard 8317.
Ustreznost embalaže, vključno s sistemom zapiranja, glede na njeno trdnost, neprepustnost in odpornost za običajni prevoz in ravnanje, je treba določiti in navesti v skladu z metodami ADR 3552, 3553, 3560, 3554, 3555, 3556 in 3558 ali v skladu z ustreznimi metodami ADR za srednje kontejnerje za razsuti tovor; in kadar se za pripravek zahteva posebno za otroke varno zapiralo, v skladu s standardi ISO 8317.
The effectiveness of the cleaning procedure must be determined, using e.g. biotests, and reported.
Učinkovitost postopka čiščenja je treba določiti ob uporabi npr. biotesta in ga navesti.
The information provided must follow from and be supported by the data provided for the micro-organism(s) and that provided under Sections 7 and 8.
Predložene informacije morajo izhajati in biti podprte s podatki za mikroorganizme in podatki iz oddelkov 7 in 8.
Where relevant pre-harvest intervals, re-entry periods or withholding periods necessary to minimise the presence of residues in or on crops, plants and plant products, or in treated areas or spaces, with a view to protecting man or livestock, must be specified e.g.:
Kadar je to relevantno, je treba podrobno navesti karenco pred spravilom, karenco za ponovni dostop in druga obdobja prepovedi uporabe, ki zagotavljajo čim manjšo vsebnost ostankov fitofarmacevtskih sredstev v kulturah, rastlinah in rastlinskih proizvodih ali na njih, na tretiranih površinah ali v prostorih, z namenom zaščite ljudi ali živine, npr:
waiting period (in days), between application and handling treated products.
karenca (v dnevih) od nanosa do ravnanja s tretiranimi proizvodi.
Where relevant, information on combustion products must be provided.
Kadar je to relevantno, je treba predložiti informacije o vnetljivih pripravkih.
Where relevant, assessment has to be done in accordance with ISO TR 9122.
Kadar je to relevantno, je treba izdelati oceno v skladu s standardom ISO TR 9122.
The nature and characteristics of protective clothing and equipment proposed must be provided.
Navesti je treba vrsto in značilnosti predlagane zaščitne obleke in opreme.
Whether arising during transport, storage or use, detailed procedures to be followed in the event of an accident, must be provided and include:
V primeru nesreče, ki nastane med prevozom, skladiščenjem ali uporabo, je treba predložiti podroben opis obveznih postopkov, ki vključujejo:
In many cases the preferred or sole means to safely dispose of plant protection products and in particular the co-formulants contained in it, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator.
V večini primerov je najprimernejši ali edini način varnega uničenja fitofarmacevtskih sredstev in zlasti pomožnih snovi v formulaciji, ki jih vsebuje, kontaminiranih materialov ali kontaminirane embalaže, nadzorovani sežig v sežigalni napravi, ki ima za to uradno dovoljenje.
The provisions of this Section only cover analytical methods required for post-registration control and monitoring purposes.
Določila tega oddelka veljajo le za analitske metode, potrebne za namene nadzora in spremljanja po registraciji.
It is desirable to have a plant protection product without contaminants, if possible.
Zaželeno je, da fitofarmacevtsko sredstvo ne vsebuje kontaminantov, če je to mogoče.
The level of acceptable contaminants shall be judged from a risk assessment point of view, by the competent authority.
O sprejemljivi količini kontaminantov presodi pristojni organ iz ocene tveganja.
Both production and product must be subject to a continuous quality control by the applicant.
Vlagatelj mora izvajati stalen nadzor kakovosti proizvodnje in proizvoda.
The quality criteria for the product shall be submitted.
Merila kakovosti za proizvod se predložijo.
Impurities, metabolites, relevant metabolites, residues
Nečistoče, metaboliti relevantni metaboliti, ostanki
Impurities, as defined above, that are of concern for human or animal health and/or the environment
nečistoče, kakor so opredeljene zgoraj, ki vzbujajo skrb za zdravje ljudi ali živali in/ali okolje
analytical standards of the pure micro-organism;
analitskih standardov čistih mikroorganizmov;
Methods, which must be described in full, must be provided for the identification and the determination of the content of the micro-organism in the preparation.
Metode, ki jih je treba natančno opisati, je treba predložiti za opredelitev in določanje vsebnosti mikroorganizma v pripravku.
In the case of a preparation containing more than one micro-organism, methods capable of identifying and determining the content of each one should be provided.
V primeru pripravka z vsebnostjo več kot enega mikroorganizma je treba predložiti metode, ki omogočajo opredelitev pripravka in določanje vsebnosti vsakega od njih.
Methods to establish regular control of the final product (preparation) in order to show that it does not contain other organisms than the indicated ones and to establish its uniformity.
Metode za vzpostavljanje rednega nadzora končnega proizvoda (pripravka) za prikaz, da ne vsebuje organizmov, ki niso navedeni, in za doseganje njegove enotnosti.
Methods to identify any contaminating micro-organisms of the preparation.
Metode za opredelitev kakršnih koli kontaminantnih mikroorganizmov v pripravku.
Methods used to determine the storage stability and shelf life of the preparation must be provided.
Metode, uporabljene za določanje stabilnosti pri skladiščenju in roka uporabe pripravka.
Methods to determine and quantify residues
Metode za določanje in količinsko vrednotenje ostankov
Analytical methods for the determination of residues, as defined in point 4.2 of Part B of the Annex to Regulation (EU) No 544/2011 must be submitted unless it is justified that the information already submitted in accordance with the requirements of point 4.2 of Part B of the Annex to Regulation (EU) No 544/2011 is sufficient.
Analitske metode za določanje ostankov, kakor so opredeljene v točki 4.2 dela B Priloge k Uredbi (EU) št. 544/2011, je treba predložiti, razen če se utemelji, da informacije, že predložene v skladu s točko 4.2 dela B Priloge k Uredbi (EU) št. 544/2011, zadostujejo.
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 ni jasnih znakov, da dejavniki okolja, kot so temperatura ali dež, ne vplivajo v večji meri na delovanje fitofarmacevtskega sredstva, je treba izvesti in navesti poskuse vpliva takih dejavnikov na delovanje, zlasti če je znano, da vplivajo na delovanje kemično sorodnih sredstev.
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 na voljo, ali s smernicami, ki izpolnjujejo vsaj zahteve iz ustreznih smernic EPPO.
The effects of plant protection products on the yield or yield components of treated plant products must be determined where relevant.
Določiti je treba učinke fitofarmacevtskih sredstev na pridelek ali na elemente pridelka tretiranih rastlinskih proizvodov, kadar je to relevantno.
This information will normally be available from the tests required under the provisions of point 6.2.
Te informacije se običajno na voljo iz testov, ki se zahtevajo 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 kakršni koli škodljivi učinki, čeprav prehodni, je treba določiti meje selektivnosti na ciljnih kulturah z dvakrat višjim odmerkom od priporočenega.
If necessary, yield measurement must be submitted.
Po potrebi je treba predložiti meritve pridelka.
Seeds testing shall be done in accordance with ISTA Methods.
Testiranje semen se izvede v skladu z metodami ISTA.
Effects on beneficial and other non-target organisms
Vplivi na koristne in druge neciljne organizme
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 patogenosti in kužnosti, je na voljo dovolj informacij o akutni toksičnosti, draženju in preobčutljivosti mikroorganizma.
If possible, additional information on mode of toxic action, toxicological profile and all other known toxicological aspects of the micro-organism shall be submitted.
Če je to mogoče, se predložijo dodatne informacije o načinu toksičnega delovanja, toksikoloških lastnostih in vseh drugih znanih toksikoloških vidikih mikroorganizma.
Special attention shall be given to co-formulants.
Posebna pozornost se nameni pomožnim snovem v formulaciji.
While performing toxicology studies, all signs of infection or pathogenicity shall be noted.
Med izvajanjem toksikoloških študij se zabeležijo vsi znaki okužbe ali patogenosti.
Toxicology studies shall include clearance studies.
Toksikološke študije vključujejo študije o izločevanju mikroorganizma.
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 544/2011.
Zlasti mora biti razvidno, da so mikroorganizem v pripravku in pogoji njegovega gojenja enaki, o čemer je treba predložiti informacije in podatke v okviru dela B Priloge k Uredbi (EU) št. 544/2011.
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 testiranja.
Basic acute toxicity studies
Osnovne študije o akutni toksičnosti
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 in oceniti, morajo zadoščati za opredelitev učinkov po enkratni izpostavljenosti fitofarmacevtskemu sredstvu, zlasti pa za določanje ali navedbo:
the toxicity of the plant protection product,
toksičnosti fitofarmacevtskega sredstva,
toxicity of the plant protection product relative to the micro-organism,
toksičnosti fitofarmacevtskega sredstva glede na mikroorganizem,
Acute inhalation toxicity
Akutna inhalacijska toksičnost
The test will provide the inhalation toxicity to rats of the plant protection product.
Test zagotavlja podatke o inhalacijski toksičnosti fitofarmacevtskega sredstva pri podganah.
is a powder containing a significant proportion of particles of diameter < 50 micrometre (> 1 % on a weight basis),
je fitofarmacevtsko sredstvo prašek z vsebnostjo znatne količine delcev s premerom < 50 mikrometrov (> 1 mas. %),
is to be applied in a manner which generates a significant proportion of particles or droplets of diameter < 50 micrometre (> 1 % on a weight basis),
se bo fitofarmacevtsko sredstvo nanašalo na način, pri katerem nastajajo znatne količine delcev ali kapljic s premerom < 50 mikrometrov (> 1 mas. %),
contains a volatile component at greater than 10 %.
fitofarmacevtsko sredstvo vsebuje več kakor 10 % hlapljivih sestavin.
Additional acute toxicity studies
Dodatne študije o akutni toksičnosti
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.
Določanje draženja kože, ki ga povzroča fitofarmacevtsko sredstvo, je obvezno, razen kadar se ne pričakuje, da bi pomožne snovi v formulaciji dražile kožo, ali je razvidno, da mikroorganizem ne draži kože, ali kadar obstaja možnost izključitve hudih kožnih reakcij, kakor je navedeno v smernicah za izvajanje testov.
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.
Določanje draženja oči, ki ga povzroči fitofarmacevtsko sredstvo, je obvezno, kadar obstaja možnost, da pomožne snovi v formulaciji dražijo oči, razen če mikroorganizem draži oči, ali kadar obstaja možnost hudih poškodb oči, kakor je navedeno v smernicah za izvajanje testov.
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.
Test je obvezen, kadar obstaja možnost, da bi pomožne snovi v formulaciji povzročale preobčutljivost kože, razen če je znano, da mikroorganizmi ali dodatki povzročajo preobčutljivost kože.
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 tiste, ki prihajajo v stik s fitofarmacevtskimi sredstvi (izvajalci tretiranja, delavci, drugi navzoči), 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 in 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 544/2011, 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. 544/2011 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 izdelavo 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 in mora biti navedena na oznaki.
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 oznaka sredstva 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.
Odločitve o potrebi po dopolnilnih študijah je treba sprejemati na podlagi posameznih primerov, ob upoštevanju rezultatov študij o akutni toksičnosti posameznih fitofarmacevtskih sredstev, možnosti izpostavljenosti kombinaciji zadevnih sredstev in razpoložljivih informacij ali praktičnih izkušenj z zadevnimi sredstvi ali podobnimi sredstvi.
Summary and evaluation of health effects
Povzetek in ocena učinkov na zdravje
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, skladno z ustreznimi merili in smernicami za ocenjevanje in odločanje, s posebnim poudarkom na možnem ali dejanskem tveganju za ljudi in živali ter obsegu, kakovosti in zanesljivosti podatkovne zbirke.
The same provisions as detailed in Section 6 of Part B of the Annex to Regulation (EU) No 544/2011 apply; 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.
Uporabljajo se iste določbe iz oddelka 6 dela B Priloge k Uredbi (EU) št. 544/2011; 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.
Special attention shall be paid towards the influence of formulation substances on the residue behaviour of the micro-organism and its metabolites.
Posebna pozornost se nameni vplivu sestavin formulacije na obnašanje ostankov mikroorganizma in njegovih metabolitov.
The same provisions as detailed in Section 7 of Part B of the Annex to Regulation (EU) No 544/2011 apply; 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 544/2011.
Uporabljajo se iste določbe iz oddelka 7 dela B Priloge k Uredbi (EU) št. 544/2011; informacije, zahtevane v skladu s tem oddelkom, je treba predložiti, razen če je mogoče na podlagi razpoložljivih podatkov oddelka 7 dela B Priloge k Uredbi (EU) št. 544/2011 ekstrapolirati končno stanje in obnašanje fitofarmacevtskega sredstva v okolju.
Effects on non-target organisms
Vplivi na neciljne organizmev
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 (flora in favna) ob predlagani uporabi.
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 544/2011, 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 testiranje vplivov na okolje temelji na informacijah o mikroorganizmu, kakor je zahtevano v delu B Priloge k Uredbi (EU) št. 544/2011, ter informacijah o pomožnih snoveh v formulaciji 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 takšnih ugotovitev bi bilo mogoče izbrati primerne testne organizme, npr. organizme 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, predložene za fitofarmacevtsko sredstvo, skupaj z drugimi relevantnimi informacijami in informacijami za mikroorganizem, zlasti zadoščajo za:
permit an evaluation whether special precautions are necessary for the protection of non-target species.
oceno potrebe po posebnih varnostnih ukrepih za zaščito neciljnih vrst.