natgillin/translations-raw huggingface dataset:
the specific information on toxicity to honeybees and other beneficial arthropods as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;
posebne informacije o toksičnosti za medonosne čebele in druge koristne členonožce iz Priloge k Uredbi (EU) št. 544/2011 ter rezultati njihove ocene;
all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011 such as:
vse relevantne informacije o fitofarmacevtskem sredstvu iz Priloge k Uredbi (EU) št. 545/2011, kot so:
effects on beneficial arthropods other than bees,
vpliv na druge koristne členonožce razen čebel,
toxicity to honeybees,
toksičnost za medonosne čebele,
available data from biological primary screening,
dostopni podatki iz osnovnega biološkega pregleda,
maximum number and timetable of applications;
največje število in časovni razpored nanosov;
Member States shall evaluate the possibility of exposure of earthworms and other non-target soil macro-organisms to the plant protection product under the proposed conditions of use; if this possibility exists they shall evaluate the degree of short-term and long-term risk to be expected to these organisms after use of the plant protection product in accordance with the proposed conditions of use.
Države članice ocenijo možnost izpostavljenosti deževnikov in drugih neciljnih makroorganizmov v tleh fitofarmacevtskemu sredstvu pri predlaganih pogojih uporabe; če ta možnost obstaja, ocenijo obseg kratkoročnega in dolgoročnega tveganja za navedene organizme, ki se lahko pričakujeta po uporabi fitofarmacevtskega sredstva pod predlaganimi pogoji uporabe.
the specific information relating to the toxicity of the active substance to earthworms and to other non-target soil macro-organisms as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;
posebne informacije o toksičnosti aktivne snovi za deževnike in druge neciljne makroorganizme v tleh iz Priloge k Uredbi (EU) št. 544/2011 ter rezultati njihove ocene;
Kd for adsorption,
Kd za adsorpcijo,
and DT90 for degradation in the soil;
in DT90 za razpad v tleh;
all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011, including the effects on earthworms and other non-target soil macro-organisms;
vse relevantne informacije o fitofarmacevtskem sredstvu iz Priloge k Uredbi (EU) št. 545/2011, vključno s vplivi na deževnike in druge neciljne makroorganizme v tleh;
the lethal and sublethal effects;
letalne in subletalne vplive;
the predicted initial and long-term environmental concentration;
predvideno začetno in dolgoročno koncentracijo v okolju;
a calculation of the acute toxicity/exposure ratio (defined as the quotient of LC50 and predicted initial environmental concentration) and of the long-term toxicity/exposure ratio (defined as the quotient of the NOEC and predicted long-term environmental concentration);
izračun razmerja med akutno toksičnostjo in izpostavljenostjo (opredeljeno kot količnik LC50 in predvidene začetne koncentracije v okolju) in razmerja med dolgotrajno toksičnostjo in izpostavljenostjo (opredeljeno kot količnik NOEC in predvidene dolgoročne koncentracije v okolju);
where relevant, the bioconcentration and persistence of residues in earthworms.
kadar je relevantno, biokoncentracijo in obstojnost ostankov v deževnikih.
Member States shall, where the evaluation carried out under point 2.5.1.1 does not exclude the possibility of the plant protection product reaching the soil under the proposed conditions of use, evaluate the impact on microbial activity such as the impact on nitrogen and carbon mineralisation processes in the soil after use of the plant protection product in accordance with the proposed conditions of use.
Kadar ocena, izdelana po točki 2.5.1.1, ne izključuje možnosti, da fitofarmacevtsko sredstvo pri predlaganih pogojih uporabe doseže tla, države članice ocenijo vpliv na mikrobiološko aktivnost, kot je vpliv na procese mineralizacije dušika in ogljika v tleh po uporabi fitofarmacevtskega sredstva pod predlaganimi pogoji uporabe.
all relevant information on the active substance, including the specific information relating to the effects of non-target soil micro-organisms as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;
vse relevantne informacije o aktivni snovi, vključno s posebnimi informacijami o vplivih na neciljne mikroorganizme v tleh iz Priloge k Uredbi (EU) št. 544/2011 ter rezultati njihove ocene;
all relevant information on the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011, including the effects on non-target soil micro-organisms;
vse relevantne informacije o fitofarmacevtskem sredstvu iz Priloge k Uredbi (EU) št. 545/2011, vključno s vplivi na neciljne mikroorganizme v tleh;
where relevant, other authorised uses of plant protection products in the area of proposed use, containing the same active substance or which give rise to the same residues;
kadar je relevantno, druge registrirane uporabe fitofarmacevtskih sredstev na območju predlagane uporabe, ki vsebujejo enako aktivno snov ali tvorijo enake ostanke.
Member States shall evaluate the analytical methods proposed for post-registration control and monitoring purposes, to determine:
Države članice ocenijo predlagane analitske metode za spremljanje in nadzor fitofarmacevtskih sredstev po registraciji, da določijo:
for formulation analysis:
za analizo formulacije:
the nature and quantity of the active substance(s) in the plant protection product and, where appropriate, any toxicologically, ecotoxicologically or environmentally significant impurities and co-formulants.
naravo in količino aktivne snovi v fitofarmacevtskem sredstvu, in kadar je ustrezno, vse toksikološko, ekotoksikološko ali okoljsko pomembne nečistoče in pomožne snovi v formulaciji.
the data on analytical methods as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;
podatki o analitskih metodah iz Priloge k Uredbi (EU) št. 544/2011 in rezultati njihove ocene;
the data on analytical methods as provided for in the Annex to Regulation (EU) No 545/2011 and in particular:
podatki o analitskih metodah iz Priloge k Uredbi (EU) št. 545/2011 in zlasti:
the specificity and linearity of the proposed methods,
specifičnost in linearnost predlaganih metod,
the importance of interferences,
pomembnost interferenc,
the precision of the proposed methods (intralaboratory repeatability and interlaboratory reproducibility);
natančnost predlaganih metod (ponovljivost znotraj laboratorija in ponovljivost med laboratoriji);
the limit of detection and determination of the proposed methods for impurities.
meja odkrivanja in določanja pri predlaganih metodah za nečistoče;
for residue analysis:
za analizo ostankov:
the residues of the active substance, metabolites, breakdown or reaction products resulting from authorised uses of the plant protection product and which are of toxicological, ecotoxicological or environmental significance.
ostanki aktivne snovi, metabolitov ter razgradnih ali reakcijskih produktov, ki nastanejo pri registriranih uporabah fitofarmacevtskih sredstev in so toksikološko, ekotoksikološko ali okoljsko pomembni.
the specificity of the proposed methods,
specifičnost predlaganih metod,
the precision of the proposed methods (intralaboratory repeatability and interlaboratory reproducibility),
natančnost predlaganih metod (ponovljivost znotraj laboratorija in ponovljivost med laboratoriji),
the recovery rate of the proposed methods at appropriate concentrations;
stopnja primerljivosti rezultatov pri ponovitvi predlaganih metod pri ustrezni koncentraciji;
the limit of detection of the proposed methods;
meja odkrivanja pri predlaganih metodah;
the limit of determination of the proposed methods.
meja določanja predlaganih metod.
Member States shall evaluate the actual active substance content of the plant protection product and its stability during storage.
Države članice ocenijo dejansko vsebnost aktivne snovi v fitofarmacevtskem sredstvu in njeno stabilnost med shranjevanjem.
Member States shall evaluate the physical and chemical properties of the plant protection product and in particular:
Države članice ocenijo fizikalne in kemijske lastnosti fitofarmacevtskega sredstva in zlasti:
where a suitable FAO (Food and Agriculture Organisation of the United Nations) specification exists, the physical and chemical properties addressed in that specification,
kadar obstaja ustrezna specifikacija Organizacije Združenih narodov za prehrano in kmetijstvo (FAO), fizikalne in kemijske lastnosti iz navedene specifikacije,
where no suitable FAO specification exists, all the relevant physical and chemical properties for the formulation as referred to in the ‘Manual on the development and use of FAO and WHO specifications for plant protection products’.
kadar ni ustreznih specifikacij FAO, vse relevantne fizikalne in kemijske lastnosti formulacije iz Priročnika za razvoj in uporabo specifikacij FAO in SZO za fitofarmacevtska sredstva.
the data on the physical and chemical properties of the active substance as provided for in the Annex to Regulation (EU) No 544/2011 and the results of the evaluation thereof;
podatki o fizikalnih in kemijskih lastnostih iz Priloge k Uredbi (EU) št. 544/2011 in rezultati njihove ocene;
the data on the physical and chemical properties of the plant protection product as provided for in the Annex to Regulation (EU) No 545/2011.
podatki o fizikalnih in kemijskih lastnostih fitofarmacevtskih sredstev iz Priloge k Uredbi (EU) št. 545/2011.
Where proposed label claims include requirements or recommendations for use of the plant protection product with other plant protection products or adjuvants as a tank mix, the physical and chemical compatibility of the products in the mixture must be evaluated.
Kadar se na predlagani oznaki zahteva ali priporoča uporaba fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi in/ali dodatki v mešanici v tanku škropilnice, morajo države članice oceniti fizikalno in kemijsko združljivost sredstev v mešanici.
Where appropriate, Member States shall impose conditions or restrictions with the authorisations they grant.
Kadar je ustrezno, države članice v postopku registracije določijo pogoje ali omejitve uporabe fitofarmacevtskega sredstva.
The nature and severity of these measures must be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise.
Vrsta in zahtevnost teh ukrepov se morata določiti na podlagi vrste in obsega pričakovanih prednosti in možnega tveganja ter morata biti tudi temu primerna.
Member States shall ensure that, where necessary, decisions taken with respect to the granting of authorisations take account of the agricultural, plant health or environmental (including climatic) conditions in the areas of envisaged use.
Države članice zagotovijo, da se pri odločitvi o registraciji po potrebi upoštevajo razmere kmetijske pridelave, zdravstvenega varstva rastlin ali okolja (vključno s podnebnimi razmerami) na predvidenih območjih uporabe.
Such considerations may result in specific conditions and restrictions of use, and, where necessary, in authorisation being granted for some but not other areas within the Member State in question.
Pri takem premisleku se lahko določijo posebni pogoji in omejitve uporabe, po potrebi pa se fitofarmacevtsko sredstvo lahko registrira samo za nekatera območja v zadevni državi članici.
Member States shall ensure that the authorised amounts, in terms of rates and number of applications, are the minimum necessary to achieve the desired effect even where higher amounts would not result in unacceptable risks to human or animal health or to the environment.
Države članice zagotovijo, da so registrirani odmerki in število nanosov čim manjši za doseganje želenega učinka, tudi kadar večje količine ne povzročajo nesprejemljivega tveganja za zdravje ljudi ali živali ali za okolje.
The authorised amounts must be differentiated in accordance with, and be appropriate to, the agricultural, plant health or environmental (including climatic) conditions in the various areas for which an authorisation is granted.
Registrirani odmerki se morajo razlikovati in biti ustrezni glede na razmere kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami) na različnih območjih, za katera je predvidena registracija.
However, the rates and the number of applications may not give rise to undesirable effects such as the development of resistance.
Vendar odmerki in število nanosov ne smejo povzročiti neželenih učinkov, kot je na primer razvoj odpornosti.
Member States shall ensure that decisions respect the principles of integrated control if the product is intended to be used in conditions where these principles are relied on.
Države članice zagotovijo, da se pri odločitvah upoštevajo načela integriranega varstva, če je proizvod namenjen za uporabo v integrirani pridelavi.
Since the evaluation is to be based on data concerning a limited number of representative species, Member States shall ensure that use of plant protection products does not have any long-term repercussions for the abundance and diversity of non-target species.
Ker mora ocena temeljiti na podatkih omejenega števila reprezentativnih vrst, države članice zagotovijo, da uporaba fitofarmacevtskih sredstev ne bo imela dolgoročnih posledic na razširjenost in raznovrstnost neciljnih vrst.
Before issuing an authorisation, Member States shall ensure that the label of the product:
Pred izdajo odločbe o registraciji, države članice zagotovijo, da oznaka proizvoda:
fulfils the requirements setting out in the Commission Regulation (EU) 547/2011 [4],
izpolnjuje zahteve iz Uredbe Komisije (EU) št. 547/2011 [4],
also contains the information on protection of users required by EU legislation on worker protection,
vsebuje tudi informacije o zaščiti uporabnikov, kakor to zahteva zakonodaja EU o varstvu pri delu,
specifies in particular the conditions or restrictions under which the plant protection product may or may not be used as referred to in points 1.1, 1.2, 1.3, 1.4 and 1.5 above.
zlasti vsebuje pogoje ali omejitve, pri katerih se fitofarmacevtsko sredstvo sme ali ne sme uporabljati, kot je določeno v prej navedenih točkah 1.1, 1.2, 1.3, 1.4 in 1.5.
The authorisation shall mention the particulars indicated in Directive 1999/45/EC of the European Parliament and of the Council [5] and in Regulation (EU) No 547/2011.1.7. Before issuing authorisations, Member States shall:
V odločbi o registraciji so navedene zahteve iz Direktive 1999/45/ES Evropskega parlamenta in Sveta [5] ter Uredbe Komisije (EU) št. 547/2011.1.7 Države članice pred izdajo odločbe o registraciji:
ensure that the proposed packaging is in accordance with the provisions of Directive 1999/45/EC;
zagotovijo, da je predlagana embalaža v skladu z določbami Direktive 1999/45/ES;
the procedures for neutralisation of the adverse effects of the product if it is accidentally dispersed, and
postopki za nevtralizacijo škodljivih učinkov sredstva pri nenamernem razlitju ter
No authorisation shall be granted unless all the requirements referred to in Section 2 are satisfied.
Če niso izpolnjene vse zahteve iz oddelka 2, se registracija ne odobri.
when one or more of the specific decision-making requirements referred to in points 2.1, 2.2, 2.3 or 2.7 are not fully satisfied, authorisations shall be granted only where the advantages of the use of the plant protection product under the proposed conditions of use outweigh the possible adverse effects of its use.
če ena ali več posebnih zahtev za odločanje iz točk 2.1, 2.2, 2.3 ali 2.7 ni v celoti izpolnjenih, se registracije odobrijo le, če prednosti uporabe fitofarmacevtskega sredstva pri predlaganih pogojih uporabe odtehtajo morebitne škodljive učinke njegove uporabe.
Any restrictions on use of the product relating to non-compliance with some of the aforementioned requirements must be mentioned on the label, and non-compliance with the requirements referred to in point 2.7 must not compromise proper use of the product.
Vse omejitve uporabe sredstva pri neizpolnjevanju nekaterih navedenih zahtev je treba navesti na oznaki, neizpolnjevanje zahtev iz točke 2.7 pa ne sme ogrožati pravilne uporabe sredstva.
advantages for and compatibility with integrated control measures or organic farming,
prednosti pri ukrepih za integrirano varstvo rastlin ali ekološko kmetovanje in združljivost z njimi,
facilitating strategies to minimise the risk of development of resistance,
spodbujanje strategij za zmanjšanje nevarnosti razvoja odpornosti,
the need for a greater diversity of types of active substances or biochemical modes of action, e.g. for use in strategies to avoid accelerated breakdown in the soil,
potreba po večji raznovrstnosti vrst aktivnih snovi ali biokemijskih načinov delovanja, npr. pri uporabi strategij za preprečevanje pospešene razgradnje v tleh,
reduced risk for operators and consumers,
manjše tveganje za izvajalce tretiranja in potrošnike,
reduced contamination of the environment and reduced impact on non-target species;
manjše onesnaženje okolja in manjši vpliv na neciljne vrste;
where the criteria referred to in point 2.6 are not fully satisfied because of limitations in current analytical science and technology, authorisation shall be granted for a limited period if the methods submitted prove adequate for the purposes intended.
kadar merila iz točke 2.6 zaradi omejenih možnosti trenutnega analitskega in tehnološkega znanja niso v celoti izpolnjena, se registracija odobri za omejeno obdobje, če se dokaže, da so predložene metode ustrezne za predvidene namene.
In this case the applicant shall be given a time limit in which to develop and submit analytical methods that are in accordance with those criteria.
V tem primeru se vlagatelju določi rok, v katerem mora razviti in predložiti analitske metode, ki so v skladu z navedenimi merili.
The authorisation shall be reviewed on expiry of the time limit accorded to the applicant;
Ob izteku roka, dodeljenega vlagatelju, se odločitev o registraciji ponovno pregleda;
where the reproducibility of the submitted analytical methods referred to in point 2.6 has only been verified in two laboratories, an authorisation shall be granted for 1 year to permit the applicant to demonstrate the reproducibility of those methods in accordance with agreed criteria.
kadar je ponovljivost predloženih analitskih metod iz točke 2.6 preverjena samo v dveh laboratorijih, se registracija odobri za eno leto, da se vlagatelju omogoči, da predloži podatke o ponovljivosti navedenih metod po predpisanih merilih.
Where an authorisation has been granted in accordance with the requirements provided for in this Annex, Member States may, by virtue of Article 44 of Regulation (EC) No 1107/2009:
Kadar je bila registracija odobrena v skladu z zahtevami iz te priloge, lahko države članice v skladu s členom 44 Uredbe (ES) št. 1107/2009:
define, where possible, preferably in close cooperation with the applicant, measures to improve the performance of the plant protection product; and/or
kadar je mogoče, opredelijo, po možnosti v tesnem sodelovanju z vlagateljem, ukrepe za izboljšanje delovanja fitofarmacevtskega sredstva in/ali
define, where possible, in close cooperation with the applicant, measures to reduce further the exposure that could occur during and after use of the plant protection product.
kadar je mogoče, opredelijo, po možnosti v tesnem sodelovanju z vlagateljem, ukrepe za nadaljnje zmanjšanje izpostavljenosti, do katere lahko pride med uporabo fitofarmacevtskega sredstva ali po njej.
Member States shall inform applicants of any measures identified under (a) or (b) and shall invite applicants to provide any supplementary data and information necessary to demonstrate performance or potential risks arising under the changed conditions.
Države članice obvestijo vlagatelje o vseh ukrepih iz odstavkov (a) ali (b) ter jih pozovejo k predložitvi dodatnih podatkov in informacij, potrebnih za prikaz učinkovitosti ali možnega tveganja v spremenjenih razmerah.
Where the proposed uses include recommendations for the control of or protection against organisms which are not considered to be harmful on the basis of experience acquired or scientific evidence under normal agricultural, plant health and environmental (including climatic) conditions in the areas of proposed use or where the other intended effects are not considered to be beneficial under those conditions, no authorisation shall be granted for those uses.
Kadar predlagane uporabe vsebujejo priporočila za nadzor ali varstvo rastlin pred organizmi, ki po pridobljenih izkušnjah ali znanstvenih dokazih ne veljajo za škodljive v razmerah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami) na območju predvidene uporabe. ali kadar drugi predvideni učinki fitofarmacevtskega sredstva v navedenih razmerah ne veljajo za koristne, se registracija ne odobri.
The level, consistency and duration of control or protection or other intended effects must be similar to those resulting from the use of suitable reference products.
Stopnja, doslednost in trajanje nadzora ali varstva ali drugih načrtovanih učinkov morajo biti podobni tistim, ki izhajajo iz uporabe ustreznih referenčnih sredstev.
If no suitable reference product exists, the plant protection product must be shown to give a defined benefit in terms of the level, consistency and duration of control or protection or other intended effects under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use.
Če ni primernega referenčnega sredstva, se mora dokazati očitna korist fitofarmacevtskega sredstva glede stopnje, doslednosti in trajanja nadzora, varstva ali drugih načrtovanih učinkov v razmerah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami) na območju predlagane uporabe.
Where relevant, yield response when the product is used and reduction of loss in storage must be quantitatively and/or qualitatively similar to those resulting from the use of suitable reference products.
Kadar je relevantno, mora imeti uporaba pripravka podoben vpliv na količino in/ali kakovost pridelka in zmanjšanje izgub med skladiščenjem kot uporaba ustreznih referenčnih sredstev.
If no suitable reference product exists, the plant protection product must be shown to give a consistent and defined quantitative and/or qualitative benefit in terms of yield response and reduction of loss in storage under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use.
Če ni primernega referenčnega sredstva, je treba dokazati dosledne in očitne koristi fitofarmacevtskega sredstva na količino in/ali kakovost pridelka ter na zmanjšanje izgub med skladiščenjem v razmerah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (vključno s podnebnimi razmerami) na območju predlagane uporabe.
Conclusions as to the performance of the preparation must be valid for all areas of the Member State in which it is to be authorised, and must hold for all conditions under which its use is proposed, except where the proposed label specifies that the preparation is intended for use in certain specified circumstances (e.g. light infestations, particular soil types or particular growing conditions).
Odločitve o delovanju pripravka morajo veljati za vsa območja države članice, v kateri se registrira, in za vse pogoje predlagane uporabe, razen kadar je na predlagani oznaki navedeno, da je fitofarmacevtsko sredstvo namenjeno le za uporabo v nekaterih posebnih okoliščinah (npr. ob lažji okužbi, na določenih vrstah tal ali v posebnih rastnih razmerah).