natgillin/translations-raw huggingface dataset:
No authorisation shall be granted if contamination of ground water, surface water or drinking water expected as a result of the use of a plant protection product under the proposed conditions of use, may cause interference with the analytical systems for the control of the quality of drinking water provided for in Directive 98/83/EC.
Registracija se ne odobri, če pričakovano onesnaženje podtalnice, površinske vode ali pitne vode zaradi uporabe fitofarmacevtskega sredstva pri predlaganih pogojih uporabe lahko povzroči motnje z analitskimi sistemi za nadzor kakovosti pitne vode iz Direktive 98/83/ES.
No authorisation shall be granted if the contamination of groundwater expected as a result of the use of a plant protection product under the proposed conditions of use contravenes or exceeds whichever of the following is the lower:
Registracija se ne odobri, če pričakovano onesnaženje podtalnice zaradi uporabe fitofarmacevtskega sredstva pri predlaganih pogojih uporabe krši ali presega eno od naslednjih vrednosti, katera koli je najnižja:
the parameters or maximum permissible concentrations laid down by Directive 98/83/EC; or
parametre ali največje dovoljene koncentracije iz Direktive 98/83/ES ali
the parameters or maximum permissible concentrations laid down for components in the plant protection product such as relevant metabolites/toxins in accordance with Directive 2000/60/EC; or
parametre ali največje dovoljene koncentracije za sestavine v fitofarmacevtskem sredstvu, npr. relevantne metabolite/toksine, iz Direktive 2000/60/ES ali
the parameters for the micro-organism or the maximum concentration laid down for components in the plant protection product such as relevant metabolites/toxins when approving the micro-organism in accordance with Regulation (EC) No 1107/2009, on the basis of appropriate data, in particular, toxicological data, or, where that concentration has not been laid down, the concentration corresponding to 1/10 of the acceptable daily intake (ADI) laid down when the micro-organism was approved in accordance with Regulation (EC) No 1107/2009,
parametre za mikroorganizem ali največja koncentracija, določena za sestavine v fitofarmacevtskem sredstvu, npr. pomembne metabolite/toksine, na podlagi ustreznih, zlasti toksikoloških podatkov ob odobritvi mikroorganizma v skladu z Uredbo (ES) št. 1107/2009, ali kadar navedena koncentracija ni določena, koncentracija, ki ustreza desetini vrednosti sprejemljivega dnevnega vnosa, določenega ob odobritvi mikroorganizma v skladu z Uredbo (ES) št. 1107/2009,
unless it is scientifically demonstrated that under relevant field conditions the lower of the parameters or concentrations is not contravened or exceeded.
razen če se znanstveno dokaže, da v relevantnih razmerah pridelave parameter ali koncentracija z najnižjo vrednostjo ne bosta kršena ali presežena.
exceeds, where the surface water in or from the area of envisaged use is intended for the extraction of drinking water, concentrations above which compliance with drinking water quality established in accordance with Directive 2000/60/EC is compromised; or
preseže, kadar je površinska voda na območju predvidene uporabe ali z njega namenjena za zajemanje pitne vode, mejne koncentracije za pitno vodo iz Direktive 2000/60/ES ali
exceeds the parameters or values for components in the plant protection product, such as relevant metabolites/toxins, established in accordance with Directive 2000/60/EC; or
preseže parametre ali vrednosti za sestavine v fitofarmacevtskem sredstvu, npr. relevantne metabolite/toksine, iz Direktive 2000/60/ES ali
has an impact deemed unacceptable on non-target species, including animals, in accordance with the relevant requirements provided for in point 2.8.
ima nesprejemljiv vpliv na neciljne vrste, vključno z živalmi, v skladu z ustreznimi zahtevami iz točke 2.8.
The proposed instruction for use of the plant protection product, including procedures for cleaning application equipment, must be such that the likelihood of accidental contamination of surface water is reduced to a minimum.
Predlagana navodila za uporabo fitofarmacevtskega sredstva, vključno s postopki za čiščenje opreme za nanašanje, morajo biti taka, da je verjetnost naključnega onesnaženja površinske vode kar najbolj zmanjšana.
No authorisation shall be granted if it is known that transfer of genetic material from the micro-organism to other organisms, may lead to unacceptable effects on the environment.
Registracija se ne odobri, če je znano, da prenos genskega materiala z mikroorganizma na druge organizme lahko pripelje do nesprejemljivih učinkov na okolje.
No authorisation shall be granted unless there is sufficient information on the possible persistence/competitiveness of the micro-organism and relevant secondary metabolites/toxins in or on the crop under the environmental conditions prevailing at and following the intended use.
Registracija se ne odobri, če ni na voljo dovolj informacij o možni obstojnosti/tekmovalnosti mikroorganizma in relevantnih sekundarnih metabolitov/toksinov v kulturi ali na njej v okoljskih razmerah, ki prevladujejo ob načrtovani uporabi in po njej.
No authorisation shall be granted if it can be expected that the micro-organism and/or its possible relevant metabolites/toxins shall persist in the environment in concentrations considerably higher than the natural background levels, taking into account repeated applications over the years, unless a robust risk assessment indicates that the risks from accumulated plateau concentrations are acceptable.
Registracija se ne odobri, če se pričakuje, da bodo mikroorganizem in/ali njegovi relevantni metaboliti/toksini ostali v okolju v precej večjih koncentracijah, kot so naravne referenčne ravni, ob upoštevanju večkratnega nanašanja v teku let, razen če groba ocena tveganja pokaže, da je tveganje ob nakopičenih največjih koncentracijah sprejemljivo.
Member States shall ensure that the available information is sufficient to permit a decision to be taken as to whether or not there may be unacceptable effects on non-target species (flora and fauna), due to exposure to the plant protection product containing the micro-organism following its intended use.
Države članice zagotovijo, da so razpoložljive informacije zadostne za odločitev, ali lahko po načrtovani uporabi pride do nesprejemljivih učinkov na neciljne vrste (flora in favna) zaradi izpostavljenosti fitofarmacevtskemu sredstvu, ki vsebuje mikroorganizem.
Member States shall pay special attention to possible effects on beneficial organisms used for biological control and organisms playing an important role in integrated control.
Države članice namenijo posebno pozornost možnim učinkom na koristne organizme, ki se uporabljajo za biološki nadzor, in na organizme, ki igrajo pomembno vlogo pri integriranem varstvu rastlin.
the micro-organism is pathogenic to birds and other non-target terrestrial vertebrates;
je mikroorganizem patogen za ptice in druge neciljne kopenske vretenčarje;
in case of toxic effects due to components in the plant protection product, such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 10 on the basis of the acute LD50 value or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable effects occur — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.
je ob toksičnih učinkih zaradi sestavin v fitofarmacevtskem sredstvu, npr. relevantnih metabolitov/toksinov, razmerje med toksičnostjo in izpostavljenostjo manjše od 10 na podlagi akutnega LD50 ali pa je dolgoročno razmerje med toksičnostjo in izpostavljenostjo manjše od 5, razen če je s primerno oceno tveganja jasno ugotovljeno, da se v razmerah pridelave ne pojavijo nesprejemljivi učinki – bodisi neposredno ali posredno – po uporabi fitofarmacevtskega sredstva pod predlaganimi pogoji uporabe.
the micro-organism is pathogenic to aquatic organisms;
je mikroorganizem patogen za vodne organizme;
in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the toxicity/exposure ratio is less than 100 in case of acute toxicity (EC50) to daphnia and fish and 10 for long-term/chronic toxicity to algae (EC50), daphnia (NOEC) and fish (NOEC), unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species occurs — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.
je ob toksičnih učinkih zaradi sestavin v fitofarmacevtskem sredstvu, npr. relevantnih metabolitov/toksinov, razmerje med toksičnostjo in izpostavljenostjo manjše od 100 pri akutni toksičnosti (EC50) za dafnije in ribe ter 10 za dolgoročno/kronično toksičnost za alge (EC50), dafnije (NOEC) in ribe (NOEC), razen če je s primerno oceno tveganja jasno ugotovljeno, da se v razmerah pridelave ne pojavi nesprejemljiv učinek na ohranitveno sposobnost izpostavljenih vrst – bodisi neposredno ali posredno – po uporabi fitofarmacevtskega sredstva pod predlaganimi pogoji uporabe.
if the micro-organism is pathogenic to bees;
če je mikroorganizem patogen za čebele;
in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product in accordance with the proposed conditions of use.
če so pri toksičnih učinkih, ki so posledica sestavin v fitofarmacevtskem sredstvu, npr. relevantnih metabolitov/toksinov, količniki nevarnosti za oralno ali kontaktno izpostavljenost medonosnih čebel večji od 50, razen če se z ustrezno oceno tveganja jasno dokaže, da uporaba fitofarmacevtskega sredstva v dejanskih razmerah predlagane uporabe nima nesprejemljivega vpliva na ličinke čebel, vedenje čebel ali preživetje in razvoj kolonije.
Where there is a possibility of arthropods other than bees being exposed, no authorisation shall be granted if:
Kadar obstaja možnost za izpostavljenost drugih členonožcev razen čebel, se registracija ne odobri:
the micro-organism is pathogenic to arthropods other than bees;
če je mikroorganizem patogen za druge členonožce razen čebel;
in case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product in accordance with the proposed conditions of use.
v primeru toksičnih učinkov, ki so posledica sestavin v fitofarmacevtskem sredstvu, npr. relevantnih metabolitov/toksinov, razen če se z ustrezno oceno tveganja jasno dokaže, da v dejanskih razmerah pridelave ni nesprejemljivega učinka na navedene organizme po uporabi fitofarmacevtskega sredstva pod predlaganimi pogoji uporabe.
Where there is a possibility of earthworms being exposed, no authorisation shall be granted if the micro-organism is pathogenic to earthworms or in the case of toxic effects due to components in the plant protection product such as relevant metabolites/toxins, the acute toxicity/exposure ratio is less than 10, or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions earthworm populations are not at risk after use of the plant protection product in accordance with the proposed conditions of use.
Kadar obstaja možnost za izpostavljenost deževnikov, se registracija ne odobri, če je mikroorganizem patogen za deževnike, ali če je pri toksičnih učinkih, ki so posledica sestavin v fitofarmacevtskem sredstvu, npr. relevantnih metabolitov/toksinov, razmerje med akutno toksičnostjo in izpostavljenostjo manjše od 10 ali pa je razmerje med dolgoročno toksičnostjo in izpostavljenostjo manjše od 5, razen če se z ustrezno oceno tveganja jasno dokaže, da v dejanskih razmerah pridelave populacije deževnikov niso ogrožene po uporabi fitofarmacevtskega sredstva pod predlaganimi pogoji uporabe.
Where there is a possibility of non-target soil micro-organisms being exposed, no authorisation shall be granted if the nitrogen or carbon mineralisation processes in laboratory studies are affected by more than 25 % after 100 days, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on the microbial community after use of the plant protection product in accordance with the proposed conditions of use, taking account of the ability of micro-organisms to multiply.
Kadar obstaja možnost izpostavljenosti neciljnih talnih mikroorganizmov, se registracija ne odobri, če se proces mineralizacije dušika ali ogljika med laboratorijskimi študijami po 100 dneh zmanjša za več kot 25 %, razen če se z ustrezno oceno tveganja jasno dokaže, da uporaba fitofarmacevtskega sredstva v dejanskih razmerah predlagane uporabe nima nesprejemljivega vpliva na mikrobiološko aktivnost, ob upoštevanju zmožnosti mikroorganizmov za razmnoževanje.
Non-extractable residues (sometimes referred to as ‘bound’ or ‘non-extracted’ residues) in plants and soils are defined as chemical species originating from pesticides used in accordance with good agricultural practice that cannot be extracted by methods which do not significantly change the chemical nature of these residues.
Neekstraktibilni ostanki (včasih imenovani „vezani“ ali „neekstrahirani“ ostanki) v rastlinah in tleh so opredeljeni kot kemijske vrste iz pesticidov, ki se uporabljajo v skladu z dobro kmetijsko prakso in jih ni mogoče ekstrahirati z metodami, ki bistveno ne spreminjajo njihove kemijske strukture.
See definition of ‘genetically modified’ in Directive 2001/18/EC.
Glej opredelitev „gensko spremenjen“ iz Direktive 2001/18/ES.
Commission Regulation (EU) No 547/2011
Uredba Komisije (EU) št. 547/2011
of 8 June 2011
z dne 8. junij 2011
implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards labelling requirements for plant protection products
o izvajanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta v zvezi z zahtevami glede označevanja fitofarmacevtskih sredstev
Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC [1], and in particular Article 65(1) thereof,
ob upoštevanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta z dne 21. oktobra 2009 o dajanju fitofarmacevtskih sredstev v promet in razveljavitvi direktiv Sveta 79/117/EGS in 91/414/EGS [1] ter zlasti člena 65(1) Uredbe,
In accordance with Regulation (EC) No 1107/2009 the labelling requirements set out in Article 16 of Directive 91/414/EEC of the Council of 15 July 1991 concerning the placing of plant protection products on the market [2] and in Annexes IV and V thereto, are to continue to apply under Regulation (EC) No 1107/2009.
V skladu z Uredbo (ES) št. 1107/2009 se zahteve glede označevanja iz člena 16 Direktive Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet [2] in iz Priloge IV in V k tej direktivi v okviru Uredbe (ES) št. 1107/2009 še naprej uporabljajo.
It is therefore necessary for the implementation of Regulation (EC) No 1107/2009 to adopt a regulation incorporating those labelling requirements for plant protection products with any necessary modifications, such as updating references.
Zato je treba za izvajanje Uredbe (ES) št. 1107/2009 sprejeti uredbo, ki vključuje te zahteve glede označevanja fitofarmacevtskih sredstev z vsemi potrebnimi spremembami, kot je posodabljanje sklicevanj.
Provisions should be included concerning re-use of packaging and concerning plant protection products which are to be used for experiments or tests for research or development purposes.
Vključene morajo biti določbe o ponovni uporabi embalaže in v zvezi s fitofarmacevtskimi sredstvi, ki se uporabljajo za preskuse ali teste v raziskovalne ali razvojne namene.
The labelling of plant protection products shall comply with the requirements, as set out in Annex I, and contain, where approriate, the standard phrases for special risks to human or animal health or to the environment, as set out in Annex II, and the standard phrases for safety precautions for the protection of human or animal health or of the environment, as set out in Annex III.
Označevanje fitofarmacevtskih sredstev je v skladu z zahtevami iz Priloge I in vključuje, kadar je primerno, standardne stavke za posebna tveganja za ljudi, živali ali okolje, kot je določeno v Prilogi II, in standardne stavke za varnostne ukrepe za zaščito ljudi, živali ali okolja, kot je določeno v Prilogi III.
Done at Brussels, 8 June 2011.
V Bruslju, 8. junija 2011
LABELLING REQUIREMENTS AS REFERRED TO IN ARTICLE 1
ZAHTEVE GLEDE OZNAČEVANJA IZ ČLENA 1
The following information shall be included clearly and indelibly on the packaging of plant protection products:
Na embalaži fitofarmacevtskih sredstev morajo biti jasno in neizbrisno navedeni naslednji podatki:
the trade name or designation of the plant protection product;
trgovsko ime ali oznaka fitofarmacevtskega sredstva;
the name and address of the holder of the authorisation and the authorisation number of the plant protection product and, if different, the name and address of the person responsible for the final packaging and labelling or for the final labelling of the plant protection product on the market;
ime in naslov imetnika registracije in številka registracije fitofarmacevtskega sredstva in, če je drugačno, ime in naslov osebe, odgovorne za končno embalažo in označevanje ali za končno označevanje fitofarmacevtskega sredstva v prometu;
the name of each active substance expressed as provided for in Article 10 (2.3) of Directive 1999/45/EC of the European Parliament and of the Council [1] with clear indication of the chemical form.
ime vsake aktivne snovi, kot to določa člen 10 (2.3) Direktive 1999/45/ES Evropskega parlamenta in Sveta [1], z jasno navedbo kemične oblike.
The name must be as given in the list contained in Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council [2] or, if not included therein, its ISO common name.
Ime mora biti zapisano tako, kot je navedeno v seznamu v Prilogi VI k Uredbi (ES) št. 1272/2008 Evropskega parlamenta in Sveta [2] ali, če ga ni na tem seznamu, s splošnim imenom ISO.
If the latter is not available, the active substance shall be designated by its chemical designation according to IUPAC rules;
Če to ne obstaja, se aktivna snov označi s kemijskim imenom v skladu s pravili IUPAC;
the concentration of each active substance expressed as follows:
koncentracija vsake aktivne snovi, izražena, kot sledi:
for solids, aerosols, volatile liquids (maximum boiling point 50 °C) or viscous liquids (lower limit 1 Pa s at 20 °C), as % w/w and g/kg,
za trdne snovi, aerosole, hlapne tekočine (vrelišče pri največ 50 °C) ali viskozne tekočine (spodnja meja 1 Pa s pri 20 °C), kot % w/w in g/kg,
for other liquids/gel formulations, as % w/w and g/l,
za druge oblike tekočin/gelov, kot % w/ww in g/l,
for gases, as% v/v and % w/w.
za pline, kot % v/v in % w/w.
If the active substance is a micro-organism, its content shall be expressed as the number of active units per volume or weight or any other matter that is relevant to the micro-organism, e.g. colony forming units per gram (cfu/g);
Če je aktivna snov mikroorganizem, se njegova vsebnost izrazi kot število aktivnih enot na obseg ali težo ali drugo zadevo, ki je pomembna za mikroorganizem, npr. delci, ki ustvarjajo kolonije, na gram (cfu/g).
the net quantity of plant protection product given in: g or kg for solid formulations, g, kg, ml or l for gases and ml or l for liquid formulations;
neto količina fitofarmacevtskega sredstva, navedena v: g ali kg za snovi v trdni obliki, g, kg, ml ali l za snovi v plinasti obliki in ml ali l za snovi v tekoči obliki;
the formulation batch number and production date;
kontrolna številka formulacije in datum proizvodnje;
information on first aid;
podatki o prvi pomoči;
the nature of any special risks to human or animal health or to the environment, by means of standard phrases selected by the competent authority, as appropriate, from those set out in Annex II;
vrsta kakršne koli posebne nevarnosti za ljudi, živali ali okolje z ustreznimi standardnimi stavki, ki jih iz stavkov iz Priloge II izbere pristojni organ, kot je primerno;
safety precautions for the protection of human or animal health or of the environment, in the form of standard phrases selected by the competent authority, as appropriate, from those set out in Annex III;
varnostni ukrepi za zaščito ljudi, živali ali okolja v obliki standardnih stavkov, ki jih iz stavkov iz Priloge III izbere pristojni organ, kot je primerno;
the type of action of the plant protection product (e.g. insecticide, growth regulator, herbicide, fungicide, etc.) and the mode of action;
vrsta delovanja fitofarmacevtskega sredstva (npr. insekticid, rastni regulator, herbicid, fungicid itd.) in način delovanja;
the type of preparation (e.g. wettable powder, emulsifiable concentrate, etc.);
formulacija (npr. močljivi prašek, koncentrat za emulzijo itd.);
the uses for which the plant protection product has been authorised and any specific agricultural, plant health and environmental conditions under which the product may be used or shall not be used;
registrirane vrste uporabe fitofarmacevtskega sredstva in vsi posebni pogoji kmetijstva, varstva rastlin in okolja, v katerih se sredstvo sme ali se ne bi smelo uporabljati;
directions for and conditions of use and the dose rate including where appropriate the maximum dose per hectare per application and the maximum number of applications per year.
navodila in pogoji za uporabo ter razmerje odmerka, vključno z, kadar je primerno, največjim odmerkom na hektar na nanašanje in največje število nanašanj na leto.
The dose rate is expressed in metric units, for each use provided for under the terms of the authorisation;
Razmerje odmerka je izraženo v merskih enotah, za vsako uporabo, določeno v skladu s pogoji iz registracije;
where appropriate, the safety interval for each use between the last application and:
kadar je primerno, za vsako vrsto uporabe varnostna čakalna doba med zadnjim nanašanjem in:
sowing or planting of the crop to be protected,
setvijo ali sajenjem pridelkov, ki se varujejo,
sowing or planting of succeeding crops,
setvijo ali sajenjem pridelkov, ki sledijo v kolobarju,
access by humans or animals,
dostopom ljudi ali živali,
harvesting,
pobiranjem pridelkov,
use or consumption;
uporabo ali porabo.
particulars of possible phytotoxicity, varietal susceptibility, and any other direct or indirect adverse side effects on plants or products of plant origin together with the intervals to be observed between application and sowing or planting of:
podatki o možni fitotoksičnosti, občutljivosti sort in vseh drugih neposrednih ali posrednih stranskih učinkih na rastline ali proizvode rastlinskega izvora s potrebnimi čakalnimi dobami med nanašanjem in setvijo ali sajenjem:
the crop in question, or
zadevnega pridelka, ali
subsequent and adjacent crops;
naslednjih in sosednjih pridelkov;
if accompanied by a leaflet, as set out in point 2, the sentence ‘Read accompanying instructions before use’;
če je priloženo navodilo za uporabo iz točke 2, stavek „Pred uporabo preberite priložena navodila“;
directions for appropriate conditions of storage, safe disposal of the plant protection product and of the packaging;
navodila za primerno skladiščenje in varno odstranjevanje fitofarmacevtskega sredstva in njegove embalaže;
where necessary, the expiry date for normal conditions of storage;
kadar je primerno, datum poteka uporabnosti ob normalnih pogojih skladiščenja;