natgillin/translations-raw huggingface dataset:
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 vplive fitofarmacevtskega sredstva na količino in/ali kakovost pridelka ter na zmanjšanje izgub med skladiščenjem v okoliščinah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (tudi podnebja) 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 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, sprejete glede delovanja pripravka, morajo veljati za vsa območja države članice, v kateri se pripravek registrira, in za vse pogoje predlagane uporabe, razen kadar je na predlagani etiketi z navodilom za uporabo navedeno, da je fitofarmacevtsko sredstvo namenjeno le uporabi v določenih posebnih okoliščinah (npr. ob lažji okužbi, na določenih vrstah tal ali posebnih rastnih razmerah).
Where proposed label claims include requirements for use of the preparation with other specified plant protection products or adjuvants as a tank mix, the mixture must achieve the desired effect and comply with the principles referred to in points 2.4.1.1 to 2.4.1.4.
Če se na predlagani etiketi z navodilom za uporabo zahteva uporaba pripravka kot mešanice skupaj z drugimi fitofarmacevtskimi sredstvi ali dodatki, mora mešanica doseči želeni učinek in biti v skladu z načeli, navedenimi v točkah 2.4.1.1 do 2.4.1.4.
Where proposed label claims include recommendations for use of the preparation with specified plant protection products or adjuvants as a tank mix, Member States shall not accept the recommendations unless they are justified.
Če se na predlagani etiketi z navodilom za uporabo priporoča uporaba pripravka skupaj z določenimi fitofarmacevtskimi sredstvi ali dodatki kot mešanica, države članice sprejmejo priporočila le, če so upravičena.
If there is evidence of a development of resistance of pathogens towards the plant protection product, the Member State shall decide if the submitted resistance management strategy addresses this adequately and sufficiently.
Če obstajajo dokazi za razvoj odpornosti patogenov zoper fitofarmacevtsko sredstvo, država članica presodi, ali predložena strategija obvladovanja odpornosti to obravnava ustrezno in zadostno.
Only plant protection products containing non-viable micro-organisms may be authorised for use to control vertebrate species.
Za nadzor vretenčarjev se lahko za uporabo registrirajo le tista fitofarmacevtska sredstva, ki vsebujejo neaktivne mikroorganizme.
The intended effect on vertebrates to be controlled shall be obtained without unnecessary suffering and unnecessary pain for these animals.
Načrtovani učinek na ciljne vretenčarje je treba doseči brez nepotrebnega povzročanja trpljenja in bolečin tem živalim.
Absence of unacceptable effects on plants and plant products
Odsotnost nesprejemljivih učinkov na rastline in rastlinske proizvode
There must be no relevant phytotoxic effects on treated plants or plant products except where the proposed label indicates appropriate limitations of use.
Fitofarmacevtsko sredstvo na tretirane rastline ali rastlinske proizvode ne sme učinkovati fitotoksično, razen kadar so v predlaganem navodilu za uporabo navedene ustrezne omejitve uporabe.
There must be no reduction of yield at harvest due to phytotoxic effects below that which could be obtained without the use of the plant protection product, unless this reduction is compensated for by other advantages such as an enhancement of the quality of the treated plants or plant products.
Pridelek ob spravilu zaradi fitotoksičnih učinkov pripravka ne sme biti manjši od pridelka, doseženega brez uporabe fitofarmacetskega sredstva, razen kadar se izgube nadomestijo z drugimi prednostmi uporabe, npr. z izboljšanjem kakovosti tretiranih rastlin ali rastlinskih proizvodov.
There must be no unacceptable adverse effects on the quality of treated plants or plant products, except in the case of adverse effects on processing where proposed label claims specify that the preparation should not be applied to crops to be used for processing purposes.
Fitofarmacevtsko sredstvo ne sme imeti nesprejemljivih škodljivih učinkov na kakovost tretiranih rastlin ali rastlinskih proizvodov, razen pri škodljivih učinkih na predelavo, kadar je v navodilu za uporabo izrecno navedeno, da se pripravek ne sme uporabljati na rastlinah, namenjenih nadaljnji predelavi.
There must be no unacceptable adverse effects on treated plants or plant products used for propagation or reproduction, such as effects on viability, germination, sprouting, rooting and establishment, except where proposed label claims specify that the preparation should not be applied to plants or plant products to be used for propagation or reproduction.
Fitofarmacevtsko sredstvo ne sme imeti nesprejemljivih škodljivih učinkov na tretirane rastline ali rastlinske proizvode, namenjene razmnoževanju ali vegetativnemu razmnoževanju, kakor so vpliv na življenjsko moč, kaljivost, odganjanje, ukoreninjenje in začetek rasti, razen če je v navodilu za uporabo izrecno navedeno, da se pripravek ne sme uporabljati na rastlinah ali rastlinskih proizvodih, namenjenih razmnoževanju ali vegetativnemu razmnoževanju.
There must be no unacceptable impact on succeeding crops, except where proposed label claims specify that particular crops, which would be affected, should not be grown following the treated crop.
Fitofarmacevtsko sredstvo ne sme imeti nesprejemljivih učinkov na posevke, ki sledijo v kolobarju, razen če je v navodilu za uporabo izrecno navedeno, da se posamezne kulture, ki bi bile prizadete, ne smejo gojiti za tretiranimi posevki.
There must be no unacceptable impact on adjacent crops, except where proposed label claims specify that the preparation should not be applied when particular sensitive adjacent crops are present.
Fitofarmacevtsko sredstvo ne sme imeti nesprejemljivih učinkov na sosednje posevke, razen če je v predlaganem navodilu za uporabo izrecno navedeno, da se pripravek ne sme uporabljati v bližini nekaterih občutljivih posevkov.
Where proposed label claims include requirements for use of the preparation with other plant protection products or adjuvants, as a tank mix, the mixture must comply with the principles referred to in points 2.4.2.1 to 2.4.2.6.
Če predlagano navodilo za uporabo vsebuje tudi zahteve za uporabo pripravka kot mešanice skupaj z drugimi fitofarmacevtskimi sredstvi ali dodatki, mora biti mešanica skladna z načeli, navedenimi v točkah 2.4.2.1 do 2.4.2.6.
The proposed instructions for cleaning the application equipment must be both practical and effective so that they can be applied with ease so as to ensure the removal of residual traces of the plant protection product which could subsequently cause damage.
Predlagana navodila za čiščenje naprav za nanašanje fitofarmacevtskega sredstva morajo biti praktična in učinkovita, njihova uporaba pa preprosta, tako da se zagotovi odstranitev sledi ostankov fitofarmacevtskega sredstva, ki bi lahko povzročili škodo.
The methods proposed must reflect the latest techniques.
Predlagane metode morajo upoštevati najnovejše tehnike.
Methods for post-authorisation monitoring should involve the use of commonly available reagents and equipment.
Metode za spremljanje po registraciji naj vključujejo tudi uporabo splošno dostopnih reagentov in opreme.
No authorisation shall be granted unless there is an adequate method of sufficient quality to identify and quantify the micro-organism and non-viable components (e.g. toxins, impurities and co-formulants) in the plant protection product.
Registracija se odobri le, če je na voljo primerna in dovolj kakovostna metoda za opredelitev in količinsko določitev mikroorganizma in neaktivnih sestavin (npr. toksinov, nečistot in pomožne snovi v formulaciji) v fitofarmacevtskem sredstvu.
In the case of a plant protection product containing more than one micro-organism, the recommended methods should be capable of identifying and determining the content of each one.
Kadar fitofarmacevtsko sredstvo vsebuje več kakor en mikroorganizem, morajo priporočene metode omogočiti opredelitev in določitev vsebnosti vsakega od njih.
No authorisation shall be granted unless there are adequate methods for post-registration control and monitoring of viable and/or non-viable residues.
Registracija se odobri le, če so na voljo ustrezne metode za nadzor in spremljanje aktivnih in/ali neaktivnih ostankov po registraciji.
Methods must be available for analysis of:
Na voljo morajo biti metode za analizo:
plants, plant products, foodstuffs of plant and animal origin and feedingstuffs if toxicologically relevant residues occur.
rastlin, rastlinskih proizvodov, živil rastlinskega in živalskega izvora in krme, če se pojavijo toksikološko pomembni ostanki.
Residues are considered relevant if a maximum residue level (MRL) or a waiting or re-entry safety period or other such precaution is required,
Ostanki se štejejo za pomembne, če se zahteva mejna vrednost ostankov (MRL/MVO), varnostna čakalna doba (karenca) ali delovna karenca ali drugi varnostni ukrepi;
soil, water, air and/or body tissues if toxicologically, ecotoxicologically or environmentally relevant residues occur.
zemlje, vode, zraka in/ali telesnih tkiv, če se pojavijo toksikološko, ekotoksikološko ali okoljsko pomembni ostanki.
Effects on human and animal health arising from the plant protection product
Učinki na zdravje ljudi in živali, ki izhajajo iz fitofarmacevtskega sredstva
No authorisation shall be granted if on the basis of the information provided in the dossier it appears that the micro-organism is pathogenic to humans or non-target animals under the proposed conditions of use.
Registracija se ne odobri, če se na podlagi predloženih informacij v dokumentaciji ugotovi, da je mikroorganizem patogen za ljudi ali neciljne živali pri predlaganih pogojih uporabe.
No authorisation shall be granted if the micro-organism and/or the plant protection product containing the micro-organism might, under the recommended conditions of use, including a realistic worst case scenario, colonise or cause adverse effects in humans or animals.
Registracija se ne odobri, če bi lahko mikroorganizem in/ali fitofarmacevtsko sredstvo, ki vsebuje mikroorganizem, pri priporočenih pogojih uporabe, vključno s stvarno najslabšim scenarijem, koloniziral ali povzročil škodljive učinke pri ljudeh ali živalih.
When making a decision on the authorisation of the microbial plant protection product, Member States shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly though the environment and at work, and animals.
Pri odločanju o registraciji fitofarmacevtskega sredstva na osnovi mikroorganizmov države članice preučijo možne učinke na vse skupine ljudi, tj. na poklicne uporabnike, nepoklicne uporabnike, ljudi, ki so sredstvu izpostavljeni neposredno ali posredno prek okolja in pri delu, ter na živali.
All micro-organisms should be regarded as potential sensitisers, unless it is established by means of relevant information that there is no risk of sensitisation, taking into account immuno-compromised and other sensitive individuals.
Vse mikroorganizme je treba obravnavati kot možne senzibilizatorje, razen če se na podlagi ustreznih informacij ugotovi, da ni tveganja za senzibilizacijo, ob upoštevanju imunsko ogroženih in drugih občutljivih posameznikov.
Authorisations granted shall therefore specify that protective clothing and suitable gloves be worn and that the plant protection product containing the micro-organism should not be inhaled.
V odobrenih registracijah mora biti zato poudarjeno, da je treba uporabljati zaščitne rokavice in da se fitofarmacevtsko sredstvo, ki vsebuje mikroorganizem, ne sme vdihavati.
Moreover, the proposed conditions of use may require use of additional items of protective clothing and equipment.
Razen tega predlagani pogoji uporabe lahko zahtevajo uporabo dodatnih (kosov) zaščitnih oblačil in opreme.
Where the proposed conditions of use require use of items of protective clothing, no authorisation shall be granted unless those items are effective and in accordance with relevant Community provisions, and are readily obtainable by the user and unless it is feasible to use them under the conditions of use of the plant protection product, taking into account climatic conditions in particular.
Če se pri predlaganih pogojih uporabe zahteva uporaba zaščitne obleke, se registracija ne odobri, če oprema ni učinkovita in v skladu z ustreznimi določbami Skupnosti ter uporabniku ni dostopna in ni enostavna za uporabo pri predvidenih pogojih uporabe fitofarmacevtskega sredstva, še zlasti ob upoštevanju podnebnih pogojev.
No authorisation shall be granted if it is known that transfer of genetic material from the micro-organism to other organisms may lead to adverse effects on human and animal health, including resistance to known therapeutic substances.
Registracija se ne odobri, če je znano, da prenos genskega materiala iz mikroorganizma na druge organizme lahko povzroči škodljive učinke na zdravje ljudi in živali, vključno z odpornostjo zoper znane zdravilne učinkovine.
Plant protection products which, because of particular properties, or which, if mishandled or misused, could lead to a high degree of risk must be subject to particular restrictions such as restrictions on the size of packaging, formulation type, distribution, use or manner of use.
Za fitofarmacevtska sredstva, ki zaradi nekaterih lastnosti ali ob napačnem rokovanju ali napačni uporabi lahko povzročijo visoko stopnjo tveganja, morajo veljati posebne omejitve, npr. glede velikosti embalaže, vrste formulacije, prodaje, uporabe ali načina uporabe.
Moreover, plant protection products which are classified as very toxic may not be authorised for use by non-professional users.
Poleg tega se fitofarmacevtska sredstva, ki so opredeljena kot zelo strupena, lahko registrirajo samo za profesionalno uporabo.
Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on bystanders or workers exposed after application of the plant protection product are expected.
Karence in delovne karence ali drugi varnostni ukrepi morajo preprečiti koloniziranje ali škodljive učinke na navzoče osebe ali delavce, ki so izpostavljeni po nanašanju fitofarmacevtskega sredstva.
Waiting and re-entry safety periods or other precautions must be established in such a way that no colonisation of or adverse effects on animals are expected.
Karence in delovne karence ali drugi varnostni ukrepi morajo biti določeni tako, da ni možnosti za koloniziranje ali škodljive učinke na živali.
Waiting and re-entry periods or other precautions to ensure that no colonisation or adverse effects are expected must be realistic; if necessary, special precautionary measures must be prescribed.
Karence in delovne karence ali drugi varnostni ukrepi, ki zagotavljajo preprečevanje koloniziranja ali škodljivih učinkov, morajo biti uresničljivi; če je potrebno, se predpišejo posebni varnostni ukrepi.
The conditions of authorisation shall be in compliance with Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work, and Directive 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.
Pogoji za registracijo morajo biti v skladu z Direktivo Sveta 98/24/ES z dne 7. aprila 1998 o varovanju zdravja in zagotavljanju varnosti delavcev pred tveganji zaradi izpostavljenosti kemičnim dejavnikom pri delu in z Direktivo 2000/54/ES Evropskega parlamenta in Sveta z dne 18. septembra 2000 o varovanju delavcev pred tveganji zaradi izpostavljenosti biološkim dejavnikom pri delu.
The experimental data and information relevant to the recognition of the symptoms of infection or pathogenicity and on the effectiveness of first aid and therapeutic measures provided shall be considered.
Treba je preučiti eksperimentalne podatke in informacije, pomembne za prepoznavanje simptomov okuženosti ali patogenosti ter o učinkovitosti prve pomoči in terapevtskih ukrepov.
The conditions of authorisation shall also be in compliance with Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work.
Pogoji registracije naj bodo tudi v skladu z Direktivo 2004/37/ES Evropskega parlamenta in Sveta z dne 29. aprila 2004 o varovanju delavcev pred nevarnostmi zaradi izpostavljenosti rakotvornim ali mutagenim snovem pri delu.
The conditions of authorisation shall also be in compliance with Council Directive 89/656/EEC of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace.
Pogoji registracije so prav tako skladni z Direktivo Sveta 89/656/EGS z dne 30. novembra 1989 o minimalnih zdravstvenih in varnostnih zahtevah za osebno varovalno opremo, ki jo delavci uporabljajo na delovnem mestu.
Effects on human and animal health arising from residues
Učinki ostankov na zdravje ljudi in živali, ki izhajajo iz fitofarmacevtskega sredstva
No authorisation shall be granted unless there is sufficient information for plant protection products containing the micro-organism, to decide that there is no harmful effect on human or animal health arising from exposure to the micro-organism, its residual traces and metabolites/toxins remaining in or on plants or plant products.
Registracija se ne odobri, če za odločitev ni na voljo zadostnih informacij o fitofarmacevtskih sredstvih, ki vsebujejo mikroorganizem, da zaradi izpostavljenosti mikroorganizmu, njegovim ostankom in metabolitom/toksinom, ki ostanejo v ali na rastlinah ali rastlinskih proizvodih, ni škodljivih vplivov na zdravje ljudi ali živali.
No authorisation shall be granted unless viable residues and/or non-viable residues occurring reflect the minimum quantities of the plant protection product necessary to achieve adequate control corresponding to good agricultural practice, applied in such a manner (including pre-harvest intervals or withholding periods or storage periods) that the viable residues and/or toxins at harvest, slaughter or after storage are reduced to a minimum.
Registracija se ne odobri, če pojav aktivnih in/ali neaktivnih ostankov ne izraža najmanjšega odmerka fitofarmacevtskega sredstva, potrebnega za ustrezno varstvo rastlin v skladu z dobro kmetijsko prakso, in če zaradi neustreznega nanosa (vključno s karencami, delovnimi karencami ali časom skladiščenja) aktivni ostanki in/ali toksini ob spravilu, zakolu ali po skladiščenju niso kar najbolj zmanjšani.
No authorisation shall be granted if the available information indicates that there may be unacceptable adverse environmental effects due to the fate and behaviour of the plant protection product in the environment.
Registracija se ne odobri, če razpoložljive informacije kažejo, da zaradi obstanka in obnašanja fitofarmacevtskega sredstva v okolju obstaja možnost za nesprejemljive škodljive vplive na okolje.
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, določenimi z Direktivo 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 od teh vrednosti je nižja:
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 of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy, or
parametre ali največje dovoljene koncentracije, določene za sestavine v fitofarmacevtskem sredstvu, npr. pomembne metabolite/toksine, v skladu z Direktivo 2000/60/ES Evropskega parlamenta in Sveta z dne 23. oktobra 2000 o določitvi okvira za ukrepe Skupnosti na področju vodne politike; ali
the parameters for the micro-organism or the maximum concentration laid down by the Commission for components in the plant protection product such as relevant metabolites/toxins when including the micro-organism in Annex I, 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 included in Annex I,
parametre za mikroorganizem ali največjo koncentracijo, ki jo je Komisija na podlagi ustreznih podatkov, zlasti toksikoloških, ob vključitvi mikroorganizma v Prilogo I določila za sestavine v fitofarmacevtskem sredstvu, npr. za pomembne metabolite/toksine, ali kjer takšna koncentracija ni predpisana, koncentracijo, ki ustreza eni desetini dopustnega dnevnega vnosa (ADI/DDV), predpisanega ob vključitvi mikroorganizma v Prilogo I,
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 dejanskih okoliščinah pridelave spodnji parametri ali koncentracije ne bodo kršeni ali preseženi.
No authorisation shall be granted if the contamination of surface water expected as a result of the use of a plant protection product under the proposed conditions of use:
Registracija se ne odobri, če pričakovano onesnaženje površinske vode zaradi uporabe fitofarmacevtskega sredstva pri predlaganih pogojih uporabe:
exceeds, where the surface water in or from the area of envisaged use is intended for the extraction of drinking water, the parameters or values established in accordance with Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States, or
preseže, kjer je površinska voda z območja predvidene uporabe namenjena za zajemanje pitne vode, parametre ali vrednosti, določene z Direktivo Sveta 75/440/EGS z dne 16. junija 1975 o zahtevah glede kakovosti površinske vode za odvzem pitne vode v državah članicah; 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. pomembne metabolite/toksine, določene z Direktivo 2000/60/ES; ali
has an impact deemed unacceptable on non-target species, including animals, according to the relevant requirements provided for in point 2.8.
ima nesprejemljiv vpliv na neciljne vrste, tudi živali, v skladu z ustreznimi zahtevami iz točke 2.8.