natgillin/translations-raw huggingface dataset:
A summary of available data from preliminary tests used to assess the biological activity and dose range finding whether positive or negative, which provides information with respect to possible impact on non-target species, both flora and fauna, must be provided, together with a critical assessment as to its relevance to potential impact on non-target species.
Predložiti je treba povzetek podatkov, ki so na voljo iz predhodnih testov, uporabljenih za oceno biološke aktivnosti in določitev odmerka ne glede na to, ali so pozitivni ali negativni, kar daje informacije v zvezi z možnim vplivom na neciljne vrste flore in favne ter kritično oceno in možni vpliv na neciljne vrste.
Summary and evaluation of Sections 9 and 10
Povzetek in ocena oddelkov 9 in 10
A summary and evaluation of all data presented in Sections 9 and 10 shall be carried out in accordance with the guidance given by the competent authorities of the Member States concerning the format of such summaries and evaluations.
Povzetek in ocena vseh podatkov iz oddelkov 9 in 10 se pripravita v skladu s smernicami pristojnih organov držav članic o obliki takih povzetkov in ocen.
It shall include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for the environment and non-target species that may or do arise, and the extent, quality and reliability of the data base.
Povzetek vključuje podrobno in kritično oceno navedenih podatkov v luči ustreznih meril in smernic za ocenjevanje in odločanje, zlasti v zvezi s tveganjem za okolje in neciljne vrste, ki iz tega izvira ali bi lahko izviralo, ter z obsegom, kakovostjo in zanesljivostjo podatkovne zbirke.
predicting distribution and fate in the environment, and the time courses involved,
napoved porazdelitve in končnega stanja fitofarmacevtskega sredstva v okolju ter časovnega poteka,
identifying non-target species and populations at risk, and predicting the extent of potential exposure,
opredelitev ogroženih neciljnih vrst in populacij ter napoved obsega njihove možne izpostavljenosti,
evaluation as to the short- and long-term risks for non-target species — populations, communities, and processes — as appropriate,
oceno kratkoročnih in dolgoročnih tveganj za neciljne vrste – populacije, skupnosti in procese – kakor je primerno,
evaluation as to the risk of fish kills, and fatalities in large vertebrates, or terrestrial predators, regardless of effects at population or community level, and
oceno tveganja za pogin rib in smrtnost pri velikih vretenčarjih ali kopenskih plenilcih, ne glede na vplive na ravni populacije ali Skupnosti, in
identification of precautions necessary to avoid or minimise contamination of the environment, and for the protection of non-target species.
opredelitev varnostnih ukrepov, potrebnih za preprečevanje ali zmanjševanje onesnaženja okolja ter zaščita neciljnih vrst.
Information on authorisations in other countries
Informacije o registracijah v drugih državah
Information on established maximum residue levels (MRL) in other countries
Informacije o določenih mejnih vrednostih ostankov (MRL) v drugih državah
Proposals including justification for the classification and labelling proposed in accordance with Regulation (EC) No 1272/2008 and Directive 1999/45/EC
Predlogi, vključno z obrazložitvijo predlogov za klasifikacijo in označevanje v skladu z Uredbo (ES) št. 1272/2008 in Direktivo 1999/45/ES
hazard symbol(s) or hazard pictograms,
Simboli ali piktogrami za nevarnost,
safety phrases or precautionary statements.
varnostni stavki ali izjave o nevarnosti.
Proposals for risk and safety in accordance with the requirements of Article 65 of Regulation (EC) No 1107/2009 and of Commission Regulation (EU) No 547/2011 [16] and proposed label.
Predlogi za simbole za nevarnost in opozorilne stavke v skladu z zahtevami iz člena 65 Uredbe (ES) št. 1107/2009 in Uredbe Komisije (EU) št. 547/2011 [16] in predlaganimi oznakami.
Specimens of proposed packaging
Vzorci predlagane embalaže
PREPARATIONS OF MICRO-ORGANISMS INCLUDING VIRUSES
PRIPRAVKI IZ MIKROORGANIZMOV, VKLJUČNO Z VIRUSI
This Part provides data requirements for the authorisation of a plant protection product based on preparations of micro-organisms including viruses.
Ta del določa zahteve glede podatkov za registracijo fitofarmacevtskega sredstva na podlagi pripravkov iz mikroorganizmov, vključno z virusi.
The term ‘micro-organism’ as defined in the introduction to Part B of the Annex to Regulation (EU) No 544/2011, also applies to the Part B of this Annex.
Izraz „mikroorganizem“, kakor je opredeljen v uvodu dela B Priloge k Uredbi (EU) št. 544/2011, se prav tako uporablja v delu B te priloge.
Where relevant, data shall be analysed using appropriate statistical methods.
Kadar je to relevantno, se analizirajo podatki ob uporabi primernih statističnih metod.
Pending the acceptance of specific guidelines at international level, the information required shall be generated using test guidelines accepted by the competent authority (e.g. USEPA guideline [17]); where appropriate test guidelines as described in Part A of the Annex to Regulation (EU) No 544/2011, shall be adapted in such a way that they are appropriate for micro-organisms.
Do sprejetja posebnih smernic na mednarodni ravni se zahtevane informacije pridobivajo ob uporabi smernic za testiranje, ki jih je sprejel pristojni organ (npr. smernice USEPA [17]); kadar je to primerno, se smernice za izvajanje testov, kakor so opisane v delu A Priloge k Uredbi (EU) št. 544/2011, prilagodijo tako, da so primerne za mikroorganizme.
Testing shall include viable and, if appropriate, non-viable micro-organisms, and a blank control.
Testiranje vključuje žive in, če je primerno, nežive mikroorganizme ter prazno kontrolo.
Where testing is done, a detailed description (specification) of the material used and its impurities, in accordance with the provisions of point 1.4, must be provided.
Pri izvajanju testov je treba podrobno opisati (specificirati) uporabljeno snov in njene nečistoče v skladu z določbami točke 1.4.
In cases where a new preparation is to be dealt with, extrapolation from Part B of the Annex to Regulation (EU) No 544/2011, could be acceptable, provided that all the possible effects of the co-formulants and other components, especially on pathogenicity and infectiveness, are also evaluated.
Pri obravnavanju novega pripravka je lahko sprejemljiva ekstrapolacija iz dela B Priloge k Uredbi (EU) št. 544/2011, če se ocenijo tudi vsi možni učinki pomožnih snovi v formulaciji in drugih sestavin, zlasti na patogenost in kužnost.
The information provided, taken together with that provided for the micro-organism(s), must be sufficient to precisely identify and define preparations.
Predložene informacije, skupaj s tistimi za mikroorganizme, morajo zadoščati za natančno opredelitev pripravkov.
This is with the view to identify if any factor could alter the properties of the micro-organism as a plant protection product in comparison to the micro-organism as such, which is treated in Part B of the Annex to Regulation (EU) No 544/2011.
To je za namene ugotavljanja, če lahko kateri koli dejavnik spremeni lastnosti mikroorganizma kot fitofarmacevtskega sredstva v primerjavi z mikroorganizmom kot takšnim, ki se obravnava v delu B Priloge k Uredbi (EU) št. 544/2011.
The name and address of the applicant must be provided as must the name, position, telephone and fax number of the appropriate person to contact.
Navesti je treba ime in naslov vlagatelja ter ime, položaj, telefonsko številko in številko telefaksa ustrezne kontaktne osebe.
Where, in addition, the applicant has an office, agent or representative in the Member State in which the authorisation is being sought, the name and address of the local office, agent or representative shall be provided, as shall the name, position, telephone and fax number of the appropriate person to contact.
Kadar ima vlagatelj poleg tega poslovalnico, zastopnika ali predstavnika v državi članici, v kateri želi pripravek registrirati, se navedejo ime in naslov lokalne poslovalnice, zastopnika ali predstavnika ter ime, položaj, telefonska številka in številka telefaksa ustrezne kontaktne osebe.
Manufacturer of the preparation and the micro-organism(s)
Proizvajalec pripravka in mikroorganizmov
The name and address of the manufacturer of the preparation and of each micro-organism in the preparation must be provided as must the name and address of each manufacturing plant in which the preparation and micro-organism are manufactured.
Navesti je treba ime in naslov proizvajalca pripravka in vsakega mikroorganizma v pripravku ter ime in naslov vsakega proizvodnega obrata, kjer poteka proizvodnja pripravka in mikroorganizma.
A contact point (preferable a central contact point, to include name, telephone and fax numbers) must be provided for each manufacturer.
Za vsakega proizvajalca je treba navesti kontaktno točko (po možnosti centralno kontaktno točko, skupaj z imenom, telefonsko številko in številko telefaksa).
If the micro-organism originates from a producer from which data in accordance with Part B of the Annex to Regulation (EU) No 544/2011 had not been submitted previously, detailed information on the name and species description, as required in point 1.3 of Part B of the Annex to Regulation (EU) No 544/2011 and on impurities, as required in point 1.4 of Part B of the Annex to Regulation (EU) No 544/2011 have to be provided.
Če mikroorganizem izdeluje proizvajalec, ki podatkov v skladu z delom B Priloge k Uredbi (EU) št. 544/2011 ni predložil predhodno, je treba predložiti podrobne informacije v zvezi z imenom in opisom vrste, kakor se zahtevajo v točki 1.3 dela B Priloge k Uredbi (EU) št. 544/2011, ter v zvezi z nečistočami, kakor se zahteva v točki 1.4 dela B Priloge k Uredbi (EU) št. 544/2011.
All former and current trade names and proposed trade names and development code numbers of the preparation referred to in the dossier as well as the current names and numbers must be provided.
Navesti je treba vsa prejšnja in zdajšnja trgovska imena in predlagana trgovska imena ter razvojne šifre pripravka iz dokumentacije, kakor tudi zdajšnja imena in številke.
Full detail of any differences must be provided.
Navesti je treba vse podrobnosti o kakršnih koli razlikah.
(The proposed trade name must not give rise to confusion with the trade name of already authorised plant protection products.)
(Predlagano trgovsko ime ne sme povzročati zmede zaradi zamenjave s trgovskim imenom že registriranih fitofarmacevtskih sredstev.)
Detailed quantitative and qualitative information on the composition of the preparation
Podrobne količinske in kakovostne informacije v zvezi s sestavo pripravka
The micro-organism shall be deposited at a recognised culture collection and given an accession number.
Mikroorganizem se deponira v priznani zbirki kultur in opremi z referenčno številko.
The scientific name must be stated, as well as the group assignment (bacteria, virus, etc.) and any other denomination relevant to the micro-organism (e.g. strain, serotype).
Navesti je treba znanstveno ime, razvrstitev po skupinah (bakterija, virus itd.) in kakršno koli drugo imenovanje, ustrezno za mikroorganizem (npr. sev, serotip).
In addition, the development phase of the micro-organism (e.g. spores, mycelium) in the marketed product shall be stated.
Poleg tega se navede razvojna faza mikroorganizma (npr. spore, micelij) v trženem proizvodu.
the content of the micro-organism(s) in the plant protection product and the content of the micro-organism in the material used for manufacturing of plant protection products.
vsebnost mikroorganizmov v fitofarmacevtskem sredstvu in vsebnost mikroorganizma v uporabljeni snovi za proizvodnjo fitofarmacevtskih sredstev.
These must include the maximum, minimum and nominal content of the viable and non-viable material,
Te navedbe morajo vključevati najvišjo, najnižjo in nominalno vsebnost živega in neživega materiala,
the content of co-formulants,
vsebnost pomožnih snovi v formulaciji,
the content of other components (such as by-products, condensates, culture medium, etc.) and contaminating micro-organisms, derived from production process.
vsebnost drugih sestavin (kot so npr. stranski produkti, kondenzati, gojišča kultur itd.) in kontaminantih mikroorganizmov, ki nastajajo med proizvodnim procesom.
The contents shall be expressed in terms as provided for in Directive 1999/45/EC for chemicals and appropriate terms for micro-organisms (number of active units per volume or weight or any other manner that is relevant to the micro-organism).
Vsebnost se izrazi v enotah iz Direktive 1999/45/ES za kemijske snovi in v primernih enotah za mikroorganizme (število aktivnih enot na prostornino ali težo ali na drug, za mikroorganizem primeren način).
Co-formulants must where possible, be identified either by their International Chemical Identification as given in Annex VI to Regulation (EC) No 1272/2008, or, if not included in that Regulation, in accordance with both IUPAC and CA nomenclature. Their structure or structural formula must be provided.
Pomožne snovi v formulaciji je treba, kadar je to primerno, opredeliti z Mednarodno kemijsko opredelitvijo iz Priloge VI k Uredbi (ES) št. 1272/2008 ali, kadar niso vključene v navedeno uredbo, v skladu z nomenklaturama IUPAC in CA. Navesti je treba njihovo strukturo ali strukturno formulo.
Identification of contaminating micro-organisms and other components derived from production process.
Opredelitev kontaminantih mikroorganizmov in drugih sestavin, ki nastajajo med proizvodnim procesom
Contaminating micro-organisms must be identified as outlined in point 1.3 of Part B of the Annex to Regulation (EU) No 544/2011.
Kontaminantne mikroorganizme je treba navesti, kakor je opisano v točki 1.3 dela B Priloge k Uredbi (EU) št. 544/2011.
Chemicals (inert components, by-products, etc.) must be identified as outlined in point 1.10 of Part A of the Annex to Regulation (EU) No 544/2011.
Kemijske snovi (inertne sestavine, stranske produkte itd.) je treba navesti, kakor je opisano v točki 1.10 dela A Priloge k Uredbi (EU) št. 544/2011.
Where the information provided does not fully identify a component, such as condensate, culture medium, etc. detailed information on the composition must be provided for each such component.
Kadar predložene informacije ne opredeljujejo natančno sestavine, kot sta npr. kondenzat, gojišče kulture itd., je treba za vsako takšno sestavino predložiti podrobne informacije o sestavi.
Physical state and nature of the preparation
Fizikalno stanje in oblika pripravka
The type and code of preparation must be designated in accordance with the ‘Catalogue of pesticide formulation types and international coding system (GIFAP Technical Monograph No 2, 1989)’.
Vrsto in šifro pripravka je treba označiti v skladu s „Katalogom vrst formulacij za pesticide in mednarodnim kodnim sistemom (Tehnična monografija EKUJS št. 2, 1989)“.
Where a particular preparation is not defined precisely in that catalogue, a full description of the physical nature and state of the preparation must be provided, together with a proposal for a suitable description of the type of preparation and a proposal for its definition.
Kadar določeni pripravek v navedenem katalogu ni natančno opredeljen, je treba predložiti izčrpen opis fizikalne oblike in fizikalnega stanja pripravka, skupaj s predlogom za ustrezen opis vrste pripravka in predlogom za njegovo opredelitev.
The biological function must be specified from among the following:
Biološko delovanje je treba opredeliti z enim od naslednjih:
The extent to which plant protection products for which authorisation is sought comply with relevant FAO specifications, as agreed by the Group of Experts on Pesticide Specification of the FAO Panel of Experts on Pesticide Specifications, Registration Requirements and Application Standards, must be stated.
Navesti je treba stopnjo skladnosti fitofarmacevtskih sredstev, za katere se zahteva registracija, z ustreznimi specifikacijami FAO, dogovorjenimi v Skupini strokovnjakov za specifikacijo pesticidov Strokovnega odbora FAO za specifikacijo pesticidov, zahtev za registracijo in standardov za zahtevke.
Storage stability and shelf-life
Stabilnost pri shranjevanju in rok uporabe
Effects of light, temperature and humidity on technical characteristics of the plant protection product
Vplivi svetlobe, temperature in vlage na tehnične značilnosti fitofarmacevtskega sredstva
The physical and biological stability of the preparation at the recommended storage temperature including information on the growth of contaminating micro-organisms must be determined and reported.
Opredeliti in navesti je treba fizikalno in biološko stabilnost pripravka pri priporočeni temperaturi shranjevanja, vključno z informacijami o rasti kontaminantnih mikroorganizmov.
The conditions under which the test has been performed must be justified.
Treba je utemeljiti pogoje, pod katerimi se je test izvajal.
Additionally in the case of liquid preparations, the effect of low temperatures on physical stability, must be determined and reported in accordance with CIPAC Methods MT 39, MT 48, MT 51 or MT 54 as appropriate.
Pri tekočih pripravkih je treba dodatno določiti in navesti vpliv nizkih temperatur na fizikalno stabilnost v skladu z metodami CIPAC MT 39, MT 48, MT 51 ali MT 54, kakor je primerno.
The shelf life of the preparation at the recommended storage temperature must be reported.
Navesti je treba rok uporabe pripravka pri priporočeni temperaturi skladiščenja.
Effect of exposure to air, packaging, etc. on the product stability must be explored.
Preučiti je treba vpliv na stabilnost pripravka zaradi izpostavljenosti zraku, embalaži itd.
Explosivity and oxidising properties will be determined as defined in point 2.2 of Part A of this Annex, unless it can be justified that it is technically or scientifically not necessary to perform such studies.
Eksplozivne in oksidacijske lastnosti se določijo, kakor je določeno v točki 2.2 dela A te priloge, razen če se lahko utemelji, da s tehničnega ali znanstvenega stališča takšnih raziskav ni treba izvajati.
Flash point and flammability must be determined, as defined in point 2.3 of Part A of this Annex, unless it can be justified that it is technically or scientifically not necessary to perform such studies.
Plamenišče in vnetljivost se določita, kakor je določeno v točki 2.3 dela A te priloge, razen če se lahko utemelji, da s tehničnega ali znanstvenega stališča takšnih študij ni treba izvajati.
Acidity, alkalinity and if necessary pH value
Kislost, bazičnost in po potrebi vrednost pH
Acidity, alkalinity and pH will be determined as defined in point 2.4 of Part A of this Annex, unless it can be justified that it is technically or scientifically not necessary to perform such studies.
Kislost, bazičnost in vrednost pH se določijo, kakor je določeno v točki 2.4 dela A te priloge, razen če se lahko utemelji, da s tehničnega ali znanstvenega stališča takšnih študij ni treba izvajati.
Viscosity and surface tension will be determined as defined in point 2.5 of Part A of this Annex, unless it can be justified that it is technically or scientifically not necessary to perform such studies.
Viskoznost in površinska napetost se določita, kakor je določeno v točki 2.5 dela A te priloge, razen če se lahko utemelji, da s tehničnega ali znanstvenega stališča takšnih študij ni treba izvajati.
If tests have to be performed, they must be done at temperatures compatible with survival of the micro-organism.
Če so testi obvezni, jih je treba izvajati pri temperaturi, primerni za preživetje mikroorganizma.
The wettability of solid preparations which are diluted for use (e.g. wettable powders and water dispersible granules), must be determined and reported in accordance with CIPAC Method MT 53.3.
Močljivost trdnih pripravkov, ki se razredčijo za uporabo (npr. močljivi praški in v vodi dispergirajoča zrnca), je treba določiti in navesti v skladu z metodo CIPAC MT 53.3.
The dust content of granular preparations, must be determined and reported in accordance with CIPAC Method MT 171.
Vsebnost prahu v zrnatih pripravkih je treba določiti in navesti v skladu z metodo CIPAC MT 171.
The dustability of dustable powders must be determined and reported in accordance with CIPAC Method MT 34 or another suitable method.
Prašljivost prašiv je treba določiti in navesti v skladu z metodo CIPAC MT 34 ali drugo ustrezno metodo.
Physical, chemical and biological compatibility with other products including plant protection products with which its use is to be authorised
Fizikalna, kemijska in biološka združljivost z drugimi sredstvi, vključno s fitofarmacevtskimi sredstvi, s katerimi se bo registrirala uporaba
The physical compatibility of recommended tank mixes must be determined and reported.
Fizikalno združljivost priporočenih mešanic v tanku škropilnice je treba določiti in navesti.
The chemical compatibility of recommended tank mixes must be determined and reported except where examination of the individual properties of the preparations would establish beyond reasonable doubt that there is no possibility of reaction taking place.
Kemijsko združljivost priporočenih mešanic v tanku škropilnice je treba določiti in navesti, razen kadar se na podlagi preučitve posameznih lastnosti pripravkov nedvoumno ugotovi, da ne obstaja možnost reakcije.
The biological compatibility of tank mixes must be determined and reported.
Biološko združljivost mešanic v tanku škropilnice je treba določiti in navesti.
Effects (e.g. antagonism, fungicidal effects) on the activity of the micro-organism after mixing with other micro-organisms or chemicals must be described.
Opisati je treba učinke (npr. antagonizem, fungicidni učinki) na delovanje mikroorganizma po mešanju z drugimi mikroorganizmi ali kemijskimi snovmi.
The possible interaction of the plant protection product with other chemical products to be applied on the crops under the expected condition of use of the preparation shall be investigated, based on the efficacy data.
Možnost medsebojne reakcije med fitofarmacevtskim sredstvom in drugimi kemijskimi proizvodi, ki se bodo nanašala na kulture pod predvidenimi pogoji uporabe pripravka, se preuči na podlagi podatkov o učinkovitosti.
Intervals between application of the biological pesticide and chemical pesticides shall be specified, if appropriate, in order to avoid loss of efficacy.
Časovni razmiki med nanosom biološkega pesticida in kemijskih pesticidov se natančno določijo za preprečevanje izgube učinkovitosti, če je to primerno.
Summary and evaluation of data presented under points 2.1 to 2.9
Povzetek in ocena podatkov iz točk 2.1 do 2.9
The field(s) of use, existing and proposed, for preparations containing the micro-organism must be specified from among the following:
Obstoječa in predlagana področja uporabe za pripravke z vsebnostjo mikroorganizma je treba podrobno določiti med naslednjimi področji uporabe:
The way by which uptake of the product may occur (e.g. contact, stomach, inhalation) or the pest controlling action (fungitoxic, fungistatic action, nutrient competition, etc.) must be stated.
Navesti je treba način vnosa sredstva (npr. stik, želodec, inhalacija) ali način delovanja za zatiranje škodljivih organizmov (fungitoksično, fungistatično delovanje, tekmovanje za hranila itd.).
It must also be stated whether or not the product is translocated in plants and, where relevant, if such translocation is apoplastic, symplastic or both.
Navesti je treba tudi podatke o premeščanju sredstva v rastlinah in, kadar je to relevantno, ali je takšno premeščanje apoplastično, simplastično ali oboje.
Details of the intended use, e.g. types of harmful organisms controlled and/or plants or plant products to be protected, must be provided.
Navesti je treba podrobnosti o predvideni uporabi, npr. vrste škodljivih organizmov, ki se jih zatira, in/ali rastline ali rastlinski proizvodi, ki se jih varuje.