natgillin/translations-raw huggingface dataset:
studies on toxicity, pathogenicity and infectivity.
študije o toksičnosti, patogenosti in infektivnosti.
For the assessment of such effects the following information should be taken into consideration:
Pri oceni takšnih učinkov je treba upoštevati naslednje informacije:
studies on toxicity to aquatic organisms,
študije o toksičnosti za vodne organizme;
If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the EC50 value and/or the NOEC value and the estimated exposure.
Če testi pokažejo umrljivost ali znake zastrupitve, mora ocena vključevati izračun razmerja med toksičnostjo in izpostavljenostjo, ki temelji na količniku EC50 in/ali NOEC ter ocenjeni izpostavljenosti.
Member States shall evaluate the possibility of exposure of and effects on bees.
Države članice ocenijo možnost izpostavljenosti in vpliva na čebele.
A micro-organism may give rise to risks because of its potential to infect and multiply in bees.
Mikroorganizem lahko povzroči tveganje zaradi svoje sposobnosti okužbe in razmnoževanja v čebelah.
studies on toxicity to bees,
študije o toksičnosti za čebele;
If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of the hazard quotient, based on the quotient of the dose in g/ha and the LD50 value in μg/bee.
Če testi pokažejo umrljivost ali znake zastrupitve, mora ocena vključevati izračun količnika možne nevarnosti, ki temelji na količniku odmerka v g/ha in količniku LD50 v μg/čebelo.
Member States shall evaluate the possibility of exposure of and effects on arthropods other than bees.
Države članice ocenijo možnost izpostavljenosti in vpliva na členonožce, razen čebel.
A micro-organism may give rise to risks because of its potential to infect and multiply in arthropods other than bees.
Mikroorganizem lahko povzroči tveganje zaradi svoje sposobnosti okužbe in razmnoževanja v členonožcih razen v čebelah.
studies on toxicity, pathogenicity and infectivity to honeybees and other arthropods.
študije o toksičnosti, patogenosti in infektivnosti za čebele in druge členonožce.
studies on toxicity to arthropods,
študije o toksičnosti za členonožce;
available data from biological primary screening.
dostopne podatke iz primarnega biološkega presejanja.
If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the ER50 value (effective rate) and the estimated exposure.
Če testi pokažejo umrljivost ali znake zastrupitve, mora ocena vključevati izračun razmerja med toksičnostjo in izpostavljenostjo, ki temelji na količniku ER50 (stopnja učinkovitosti) in ocenjeni izpostavljenosti.
Member States shall evaluate the possibility of exposure of and effects on earthworms.
Države članice ocenijo možnost izpostavljenosti in vpliva na deževnike.
A micro-organism may give rise to risks because of its potential to infect and multiply in earthworms.
Mikroorganizem lahko povzroči tveganje zaradi svoje sposobnosti okužbe in razmnoževanja v deževnikih.
studies on earthworm toxicity, pathogenicity and infectivity.
študije o toksičnosti, patogenosti in infektivnosti za deževnike.
studies on earthworm toxicity,
študije o toksičnosti za deževnike;
If mortality or signs of intoxication are observed in the tests the evaluation must include a calculation of toxicity/exposure ratios based on the quotient of the LC50 value and the estimated exposure expressed in mg/kg dry weight soil.
Če testi pokažejo umrljivost ali znake zastrupitve, mora ocena vključevati izračun razmerja med toksičnostjo in izpostavljenostjo, ki temelji na količniku LC50 in ocenjeni izpostavljenosti, izraženi v mg/kg teže suhe zemlje.
Member States shall evaluate the possibility of exposure of and effects on soil micro-organisms.
Države članice ocenijo možnost izpostavljenosti in vpliva na talne mikroorganizme.
A micro-organism may give rise to risks because of its potential to interfere with nitrogen and carbon mineralisation in the soil.
Mikroorganizem lahko povzroči tveganje zaradi svoje sposobnosti motenja mineralizacije dušika in ogljika v tleh.
other biological properties.
druge biološke lastnosti.
Experimental data are not normally required, i.e. where it can be justified that a proper risk assessment can be performed with the available information.
Podatki o poskusu se običajno ne zahtevajo, tj., kadar se lahko utemelji, da dostopne informacije omogočajo ustrezno oceno tveganja.
Member States shall evaluate the impact of exotic/non-indigenous micro-organisms on non-target micro-organisms and on their predators following use of the plant protection product according to the proposed conditions of use.
Države članice ocenijo učinek eksotičnih/neavtohtonih mikroorganizmov na neciljne mikroorganizme ter na njihove plenilce po uporabi fitofarmacevtskega sredstva v skladu s predlaganimi pogoji uporabe.
all available information from biological primary screening.
vse dostopne informacije iz primarnega biološkega presejanja.
Member States shall draw conclusions on the need for further information and/or testing and the need for measures to limit the risks arising.
Države članice sprejmejo zaključke o potrebi po dodatnih informacijah in/ali poskusih in ukrepih za omejitev tveganja.
Member States shall justify proposals for the classification and labelling of plant protection products.
Države članice utemeljijo predloge za razvrstitev in označevanje fitofarmacevtskih sredstev.
Where appropriate, Member States shall impose conditions or restrictions on the authorisations they grant.
Kjer je ustrezno, države članice v postopku registracije določijo pogoje ali omejitve uporabe fitofarmacevtskega sredstva.
The nature and severity of these conditions or restrictions 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 strogost teh pogojev in omejitev se določita na osnovi narave in obsega pričakovanih prednosti in možnega tveganja ter morata biti tudi temu primerna.
Member States shall ensure that decisions taken to grant 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 odločanju o odobritvi registracij upoštevajo okoliščine kmetijske pridelave, zdravstvenega stanja rastlin ali okolja (vključno s podnebjem) na območjih predvidene uporabe.
Such considerations may result in specific conditions and restrictions on use, and, in authorisation being granted for some but not other areas within the Member State in question.
Pri takšnem upoštevanju se lahko določijo posebni pogoji in omejitve uporabe, fitofarmacevtsko sredstvo pa se lahko registrira samo za uporabo na posameznem, ne pa tudi preostalih območjih 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 nanašanja najmanjši možni 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 according to, 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 okoliščine kmetijske pridelave, zdravstvenega stanja rastlin in okolja (tudi podnebja) 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 pa odmerki in število nanosov ne smejo povzročiti neželenih učinkov, kakršen je na primer razvoj odpornosti.
Member States shall ensure that decisions respect the principles of integrated pest control if the plant protection product is intended for use in conditions where these principles are relied on.
Države članice zagotovijo, da se pri sprejemanju odločitev upoštevajo načela integriranega varstva pred škodljivci, če je fitofarmacevtsko sredstvo namenjeno 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 raznolikost neciljnih vrst.
Before issuing an authorisation, Member States shall ensure that the label of the plant protection product:
Pred izdajo odločbe o registraciji države članice zagotovijo, da etiketa z navodilom za uporabo na fitofarmacevtskem sredstvu:
fulfils the requirements of Article 16 of this Directive,
izpolnjuje zahteve iz člena 16 te direktive;
also contains the information on protection of users required by Community legislation on worker protection,
vsebuje tudi informacije o zaščiti uporabnikov, kakor to zahteva zakonodaja Skupnosti 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 to 1.5,
določa zlasti pogoje ali omejitve, pod katerimi se fitofarmacevtsko sredstvo sme ali ne sme uporabljati, kakor je določeno v točkah od 1.1 do 1.5;
The authorisation shall mention the particulars indicated in Article 16(1)(g) and (h) of this Directive and Article 10(1.2), (2.4), (2.5) and (2.6) of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations.
v registraciji se navedejo podatki iz člena 16(1)(g) in (h) te direktive in člena 10(1.2), (2.4), (2.5) in (2.6) Direktive 1999/45/ES Evropskega parlamenta in Sveta z dne 31. maja 1999 o približevanju zakonov in drugih predpisov držav članic v zvezi z razvrščanjem, pakiranjem in označevanjem nevarnih pripravkov.
Before issuing authorisations, Member States shall:
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 skladna z določbami Direktive 1999/45/ES;
ensure that:
zagotovijo, da so:
the procedures for destruction of the plant protection product,
postopki za uničenje fitofarmacevtskega sredstva,
the procedures for neutralisation of any adverse effects of the plant protection product if it is accidentally dispersed, and
postopki za nevtralizacijo škodljivih vplivov fitofarmacevtskega sredstva pri nenamernem razlitju, in
the procedures for the decontamination and destruction of the packaging,
postopki za dekontaminacijo in uničenje embalaže
are in accordance with the relevant regulatory provisions.
v skladu z ustreznimi predpisi.
No authorisation shall be granted unless all the requirements referred to in point 2 are satisfied.
Če niso izpolnjene vse zahteve iz točke 2 tega poglavja, se registracija ne odobri.
However, when one or more of the specific decision-making requirements referred to in point 2.4 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.
Kljub temu se v primeru, pri katerem ena ali več posebnih zahtev pri odločanju iz točke 2.4 ni v celoti izpolnjenih, registracije odobrijo le, če prednosti uporabe fitofarmacevtskega sredstva v predlaganih pogojih uporabe prevladajo nad možnimi škodljivimi učinki njegove uporabe.
Any restrictions on use of the plant protection product relating to non-compliance with some of the requirements referred to in point 2.4 must be mentioned on the label.
Vse omejitve glede uporabe fitofarmacevtskega sredstva, povezane z neizpolnjevanjem nekaterih zahtev iz točke 2.4, morajo biti navedene na etiketi z navodilom za uporabo.
These advantages can be in terms of:
Te prednosti so lahko:
advantages for and compatibility with integrated control measures or organic farming,
prednosti za ukrepe integriranega varstva rastlin ali ekološkega kmetovanja in združljivost z njimi;
facilitating strategies to minimise the risk of development of resistance,
pospeševanje strategij za zmanjšanje nevarnosti razvoja odpornosti;
reduced risk for operators and consumers,
zmanjšano tveganje za uporabnike in potrošnike;
reduced contamination of the environment and reduced impact on non-target species.
zmanjšano onesnaženje okolja in zmanjšan vpliv na neciljne vrste.
Where an authorisation has been granted according to the requirements provided for in this Annex, Member States may, by virtue of Article 4(6):
Kadar je bila registracija odobrena v skladu z zahtevami iz te priloge, lahko države članice skladno s členom 4(6):
define, where possible, preferably in close cooperation with the applicant, measures to improve the performance of the plant protection product, and/or
opredelijo, kjer je možno, 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.
opredelijo, kjer je možno, v tesnem sodelovanju z vlagateljem, ukrepe za nadaljnje zmanjšanje izpostavljenosti, ki je možna 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, opredeljenih pod (a) ali (b), ter jih pozovejo k predložitvi dodatnih podatkov in informacij, potrebnih za prikaz učinkovitosti ali možnega tveganja, ki je mogoče v spremenjenih razmerah.
Member States shall ensure, as far as is practically possible, that for all micro-organisms that are considered for an authorisation, the applicant has taken into account all available relevant knowledge and information in literature at the time of submission.
Države članice kar najbolj zagotovijo, da vlagatelj glede vseh mikroorganizmov, na katere se nanaša zahtevek za registracijo, upošteva vsa ustrezna spoznanja in podatke iz literature, ki so na voljo ob vložitvi zahtevka.
Where the micro-organism has been genetically modified, as defined in Directive 2001/18/EC, no authorisation shall be granted unless the evaluation conducted in accordance with Directive 2001/18/EC has been submitted, as required under Article 1(3) of that Directive.
Če je mikroorganizem gensko spremenjen, kakor je opredeljeno v Direktivi 2001/18/ES, se registracija ne odobri, razen če se ne predloži ocena, ki je bila izvedena v skladu z Direktivo 2001/18/ES, kot to zahteva člen 1(3) te direktive.
The relevant decision taken by the competent authorities in accordance with Directive 2001/18/EC must be provided.
Treba je predložiti ustrezno odločitev, ki so jo pristojni organi sprejeli v skladu z Direktivo 2001/18/ES.
In accordance with Article 1(3) of this Directive, no authorisation shall be granted for a plant protection product containing a genetically modified organism unless authorisation is granted according to the provisions in Directive 2001/18/EC, part C, under which that organism can be released into the environment.
V skladu s členom 1(3) te direktive se registracija za fitofarmacevtsko sredstvo, ki vsebuje gensko spremenjen organizem, ne odobri, razen če se registracija odobri v skladu z določbami iz dela C Direktive 2001/18/ES, po katerih se ta organizem lahko spusti v okolje.
No authorisation shall be granted if relevant metabolites/toxins (i.e. those expected to be of concern for human health and/or the environment) known to be formed by the micro-organism, and/or by microbial contaminants are present in the plant protection product, unless it can be shown that the amount present is at an acceptable level before and after its proposed use.
Če so v fitofarmacevtskem sredstvu prisotni pomembni metaboliti/toksini (tj. tisti, ki so po predvidevanju nevarni za zdravje ljudi in/ali okolje), za katere je znano, da jih tvorijo mikroorganizmi in/ali mikrobiološki onesnaževalci, se registracija ne odobri, razen če je mogoče dokazati, da je prisotna količina pred predlagano uporabo fitofarmacevtskega sredstva in po njej na sprejemljivi ravni.
Member States shall ensure that adequate quality control measures are applied to ensure the identity of the micro-organism and contents of the plant protection product.
Države članice zagotovijo uporabo ustreznih ukrepov za nadzor kakovosti, s katerimi se poskrbi za identiteto mikroorganizma in vsebnost v fitofarmacevtskem sredstvu.
Such measures must include a Hazard Analysis Critical Control Point (HACCP) system or equivalent system.
Tovrstni ukrepi za nadzor kakovosti morajo vključevati sistem analize tveganja in kritičnih nadzornih točk (HACCP) ali ustrezen enakovreden sistem.
The specific principles shall apply without prejudice to the general principles referred to in Section 1.
Posebna načela se uporabljajo brez poseganja v splošna načela iz oddelka 1.
For each authorisation granted the Member States shall ensure that the micro-organism concerned is deposited at an internationally recognised culture collection and has an accession number.
Za vsako odobreno registracijo države članice zagotovijo, da je zadevni mikroorganizem deponiran v mednarodno priznani zbirki kultur in opremljen z referenčno številko vnosa.
Each micro-organism must be identified and named at the species level and characterised at the strain level.
Vsak mikroorganizem je treba identificirati in poimenovati na ravni vrste in opredeliti na ravni seva.
There must also be information as to whether or not the micro-organism is a wild type or a spontaneous or induced mutant, or a genetically modified organism.
Navesti je treba tudi podatke, ali gre za mikroorganizem divje vrste, spontanega ali induciranega mutanta, ali za gensko spremenjeni organizem.
There must be sufficient information to permit assessment of the minimum and maximum content of the micro-organism in the material used for the manufacturing of plant protection products, as well as in the plant protection product.
Za oceno najmanjše in največje vsebnosti mikroorganizma v materialu, ki se uporablja za proizvodnjo fitofarmacevtskih sredstev, in v fitofarmacevtskem sredstvu mora biti na voljo dovolj informacij.
The content of other components and formulants in the plant protection product and contaminating micro-organisms derived from the production process must to the extent possible be defined.
Vsebnost drugih sestavin in pomožnih snovi v formulaciji v fitofarmacevtskem sredstvu in kontaminantnih mikroorganizmov, ki nastanejo med proizvodnim procesom, je treba kar najbolje opredeliti.
Member States shall ensure that the level of contaminating organisms is controlled to an acceptable level.
Države članice zagotovijo, da se stopnja kontaminantnih mikroorganizmov nadzorovano zadržuje na dopustni ravni.
In addition: the physical nature and state of the plant protection product must be specified, preferably according to the ‘Catalogue of pesticide formulation types and international coding system (CropLife International Technical Monograph No 2, 5th Edition, 2002)’.
Poleg tega je treba navesti fizikalne lastnosti in stanje fitofarmacevtskega sredstva, po možnosti v skladu s ‚Katalogom vrst formulacij za pesticide in mednarodnim kodnim sistemom (Mednarodna tehnična monografija CropLife št. 2, 5. izdaja, 2002)‘.
No authorisation shall be granted if, at any stage in the development of a microbial plant protection product, it becomes apparent, on the basis of a build-up of resistance, or transfer of resistance, or other mechanism, that there may be interference with the effectiveness of an anti-microbial agent used in human or animal medicine.
Registracija se ne odobri, če se na kateri koli razvojni stopnji fitofarmacevtskega sredstva na osnovi mikroorganizma izkaže (na podlagi okrepljene odpornosti, prenosa odpornosti ali drugega mehanizma), da bi bila lahko motena učinkovitost antimikrobiološkega sredstva, ki se uporablja v človeški medicini ali veterini.
No authorisation shall be granted unless full information is provided on the continuous quality control of the production method, production process and plant protection product.
Brez predložitve popolnih informacij o nenehnem nadzoru kakovosti proizvodne metode, proizvodnega postopka in fitofarmacevtskega sredstva se registracija ne odobri.
In particular, the occurrence of spontaneous changes in major characteristics of the micro-organism and the absence/presence of contaminating organisms shall be considered.
Upoštevati je treba zlasti spontane spremembe glavnih značilnosti mikroorganizma in odsotnost/prisotnost bistvenih kontaminantnih organizmov.
The quality assurance criteria for production and the techniques used to ensure a uniform plant protection product must to the extent possible be described and specified.
Kar najbolj je treba opisati in opredeliti merila za zagotavljanje kakovosti in metode, ki se uporabljajo za zagotavljanje enotnosti fitofarmacevtskega sredstva.
Performance
Delovanje
No authorisation shall be granted 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.
Kadar predlagana uporaba vključuje priporočila za nadzor ali varstvo pred organizmi, ki ne veljajo za škodljive na podlagi pridobljenih izkušenj ali znanstvenih dokazov v okoliščinah kmetijske pridelave, zdravstvenega stanja rastlin in okolja (tudi podnebja) na območju predlagane uporabe, ali kadar drugi predvideni učinki fitofarmacevtskega sredstva v teh okoliščinah ne veljajo za koristne, se registracija za to uporabo 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 drugi načrtovani učinki 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 v smislu stopnje, doslednosti in trajanja nadzora, varstva, ali drugih načrtovanih učinkov v okoliščinah kmetijske pridelave, zdravstvenega varstva rastlin in okolja (tudi podnebja) na območju predlagane uporabe.
Where relevant, yield response when the plant protection 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.
Kjer je ustrezno, mora imeti uporaba fitofarmacevtskega sredstva podoben vpliv na količino in/ali kakovost pridelka in zmanjšanje izgub med skladiščenjem kakor uporaba ustreznih referenčnih sredstev.