natgillin/translations-raw huggingface dataset:
The information shall include the proposed classification and labelling of the plant protection product in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council [2], where relevant.
Kadar je ustrezno, informacije vključujejo predlagano razvrstitev in označevanje fitofarmacevtskega sredstva v skladu z Uredbo (ES) št. 1272/2008 Evropskega parlamenta in Sveta [2].
Information as provided for in Commission Regulation (EU) No 283/2013 [3] may be required by the competent authorities on co-formulants.
Pristojni organi lahko v zvezi z dodatki zahtevajo informacije iz Uredbe Komisije (EU) št. 283/2013 [3].
Before requiring additional studies to be performed, the competent authorities shall assess all available information provided in accordance with other Union legislation.
Preden se zahteva izvedba dodatnih študij, pristojni organi ocenijo vse razpoložljive informacije, zagotovljene v skladu z drugo zakonodajo Unije.
The information provided for the plant protection product and that provided for the active substance, shall be sufficient to:
Informacije, predložene v zvezi s fitofarmacevtskim sredstvom, in informacije, predložene v zvezi z aktivno snovjo, zadoščajo za:
decide whether, or not, the plant protection product is to be authorised;
odločitev o registraciji fitofarmacevtskega sredstva;
specify conditions or restrictions to be associated with any authorisation;
opredelitev pogojev ali omejitev v zvezi z vsako registracijo;
permit a risk assessment of acute and chronic consumer exposure, including, where relevant, a cumulative risk assessment deriving from exposure to more than one active substance;
oceno učinka akutne in kronične izpostavljenosti potrošnikov, vključno s kumulativno oceno tveganja, ki temelji na izpostavljenosti več kot eni aktivni snovi, kadar je to ustrezno;
permit an estimation of acute and chronic exposure to operators, workers, residents and bystanders including, where relevant, the cumulative exposure to more than one active substance;
oceno akutne in kronične izpostavljenosti izvajalcev tretiranja, delavcev, prebivalcev in drugih navzočih oseb, vključno s kumulativno izpostavljenostjo več kot eni aktivni snovi, kadar je ustrezno;
permit an evaluation to be made as to the nature and extent of the risks for humans, animals (species normally fed and kept by humans or food producing animals) and of the risks for other non-target vertebrate species;
oceno glede vrste in obsega tveganja za ljudi in živali (predvsem vrste, ki jih običajno krmijo in redijo ljudje, ter živali, namenjene za proizvodnjo hrane) ter tveganj za druge neciljne vrste vretenčarjev;
predict the distribution, fate, and behaviour in the environment, as well as the time courses involved;
predvidevanje porazdelitve, končnega stanja in obnašanja v okolju ter časovnih potekov v teh procesih;
permit an assessment of the impact of the plant protection product on non target species;
oceno vpliva fitofarmacevtskega sredstva na neciljne vrste;
classify the plant protection product as to hazard in accordance with Regulation (EC) No 1272/2008.
razvrstitev fitofarmacevtskega sredstva glede na nevarnost v skladu z Uredbo (ES) št. 1272/2008.
Where relevant, tests shall be designed and data analysed using appropriate statistical methods.
Kadar je ustrezno, se na podlagi ustreznih statističnih metod načrtujejo preskusi in analizirajo podatki.
Exposure calculations shall refer to scientific methods accepted by the European Food Safety Authority (the Authority), when available.
Izračuni izpostavljenosti se sklicujejo na znanstvene metode, ki jih je sprejela Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija), kadar so na voljo.
Additional methods, when used, shall be justified.
Morebitna uporaba dodatnih metod se utemelji.
Additional requirements at national level may be necessary in specific circumstances, that is to say specific scenarios, patterns of use other than those taken into account for approval.
V posebnih okoliščinah, tj. pri posebnih scenarijih, vzorcih uporabe, ki se ne upoštevajo pri odobritvi, so morda potrebne dodatne zahteve na nacionalni ravni.
By way of derogation from point 3.1, tests and analyses, required under the provisions of Sections 6 of Parts A and B, may be conducted by official or officially recognised testing facilities or organisations which satisfy at least the following requirements:
Z odstopanjem od točke 3.1 lahko preskuse in analize, ki so obvezni v skladu z določbami iz oddelka 6 delov A in B, izvajajo uradni ali uradno priznani preskuševalni laboratoriji ali organizacije, ki izpolnjujejo vsaj naslednje zahteve:
they have at their disposal sufficient scientific and technical staff having the necessary education, training, technical knowledge and experience for their assigned functions;
na voljo imajo dovolj znanstvenega in tehničnega osebja s potrebno izobrazbo, usposobljenostjo, tehničnim znanjem in izkušnjami za dodeljene naloge;
they have at their disposal suitable equipment required for correct performance of the tests and measurements which they claim to be competent to carry out;
na voljo imajo ustrezno opremo, potrebno za pravilno izvajanje preskusov in meritev, ki naj bi jih bile merodajne izvesti;
that equipment is properly maintained and calibrated, where appropriate, before being put into service and thereafter according to an established programme;
ta oprema mora biti ustrezno vzdrževana in kalibrirana, kadar je primerno, pred začetkom uporabe, pozneje pa v skladu z določenim programom;
they have at their disposal appropriate experimental fields and, where necessary glasshouses, growth cabinets or storage rooms;
na voljo imajo ustrezen poskusni teren in po potrebi steklenjake, rastne omare ali skladiščne prostore;
the environment in which the tests are undertaken shall not invalidate their results or adversely effect the required accuracy of measurement;
okolje, v katerem se izvajajo preskusi, ne sme povzročiti razveljavitve rezultatov ali škodljivo vplivati na zahtevano točnost meritev;
they make available to all relevant personnel operating procedures and protocols used for the trials;
vsemu ustreznemu osebju dajo na voljo operativne postopke in predpise, ki se uporabljajo za poskuse;
they make available, where requested by the competent authority, prior to the commencement of a test, information on its location and on the tested plant protection products;
na zahtevo pristojnega organa pred začetkom izvajanja preskusa dajo na voljo informacije o kraju izvajanja preskusa in preskušanih fitofarmacevtskih sredstvih;
they ensure that the quality of the work performed is appropriate to its type, range, volume and intended purpose;
zagotovijo, da kakovost izvedenega dela ustreza vrsti, obsegu, količini in predvidenemu namenu;
they maintain records of all observations, calculations and derived data and calibrations records and final test report as long as the product concerned is authorised in a Member State.
hranijo evidence o vseh opažanjih, izračunih in izpeljanih podatkih, evidence o kalibriranju ter končno poročilo o preskusu, če je zadevno sredstvo registrirano v državi članici.
Officially recognised testing facilities and organisations, and, where requested by the competent authorities, official facilities and organisations shall:
Uradno priznani preskuševalni laboratoriji in organizacije ter na zahtevo pristojnih organov uradni laboratoriji in organizacije:
report to the relevant national authority all information necessary to demonstrate that they can satisfy the requirements provided for in point 3.2,
sporočijo ustreznemu nacionalnemu organu vse potrebne informacije za dokaz, da lahko izpolnjujejo zahteve iz točke 3.2,
permit at any time the inspections, which each Member State shall regularly organise on its territory in order to verify the compliance with point 3.2.
kadar koli dovolijo inšpekcijske preglede, ki jih vsaka država članica redno organizira na svojem ozemlju za preverjanje skladnosti s točko 3.2.
For active substances consisting of micro-organisms or viruses, tests and analyses performed to obtain data on their properties and safety with respect to other aspects than human health, may be conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements specified at points 3.2 and 3.3.
V zvezi z aktivnimi snovmi, ki so sestavljene iz mikroorganizmov ali virusov, lahko preskuse in analize za pridobivanje podatkov o lastnostih in varnosti v zvezi z vidiki, ki niso povezani z zdravjem ljudi, izvajajo uradni ali uradno priznani preskuševalni laboratoriji ali organizacije, ki izpolnjujejo vsaj zahteve iz točk 3.2 in 3.3.
Studies conducted before the application of this Regulation, although not fully compliant with GLP requirements or with current test methods, may be integrated into the assessment, when accepted by the competent authorities as scientifically valid, thereby removing the need for repeating animal tests, especially for carcinogenicity and reprotoxicity studies.
Študije, ki so bile izvedene pred začetkom uporabe te uredbe, se lahko, čeprav niso popolnoma skladne z zahtevami DLP ali sedanjimi preskusnimi metodami, vključijo v oceno, če jih pristojni organi potrdijo kot znanstveno veljavne, s čimer preskusov na živali, zlasti pri študijah rakotvornosti in reproduktivne toksičnosti, ni treba ponoviti.
Due to the influence that impurities and other components can have on toxicological and ecotoxicological behaviour, a detailed description (specification) of the material used shall be provided for each study submitted.
Zaradi vpliva, ki ga lahko imajo nečistoče in druge sestavine na toksikološko in ekotoksikološko obnašanje, se za vsako predloženo študijo navede podroben opis (specifikacija) uporabljene snovi.
Studies shall be conducted using the plant protection product to be authorised or bridging principles may be applied, for example use of a study on a product with a comparable/equivalent composition.
Pri izvajanju študij se uporabi fitofarmacevtsko sredstvo, ki je v postopku registracije, uporabijo pa se lahko tudi premostitvena načela, na primer študija o sredstvu s primerljivo/enako sestavo.
A detailed description of the composition used shall be provided.
Navede se podroben opis uporabljene sestave.
Where radio-labelled test material is used, radio-labels shall be positioned at sites (one or more as necessary), to facilitate elucidation of metabolic and transformation pathways and to facilitate investigation of the distribution of the active substance and of its metabolites, breakdown and reaction products.
Kadar se uporablja preskusna snov, označena z radioaktivnimi markerji, se radioaktivni markerji postavijo na enega ali (po potrebi) več mest, ki omogočajo pojasnitev poti presnove in transformacije ter preiskavo porazdelitve aktivne snovi in njenih metabolitov ter razgradnih in reakcijskih produktov.
The principles of replacement, reduction and refinement of the use of vertebrate animals shall be fully taken into account in the design of the test methods, in particular when appropriate validated methods become available to replace, reduce or refine animal testing.
Načela nadomestitve, zmanjšanja in izboljšanja uporabe vretenčarjev se v celoti upoštevajo pri načrtovanju preskusnih metod, zlasti če so na voljo ustrezne potrjene metode, ki lahko nadomestijo, zmanjšajo ali izboljšajo preskuse na živalih.
CHEMICAL PLANT PROTECTION PRODUCTS
KEMIJSKA FITOFARMACEVTSKA SREDSTVA
Identity of the plant protection product
Opredelitev fitofarmacevtskega sredstva
Producer of the plant protection product and the active substances
Proizvajalec fitofarmacevtskega sredstva in aktivnih snovi
Trade name or proposed trade name and producer’s development code number of the plant protection product if appropriate
Trgovsko ime ali predlagano trgovsko ime in po potrebi proizvajalčeva razvojna šifra fitofarmacevtskega sredstva
Detailed quantitative and qualitative information on the composition of the plant protection product
Podrobne količinske in kvalitativne informacije v zvezi s sestavo fitofarmacevtskega sredstva
Composition of the plant protection product
Sestava fitofarmacevtskega sredstva
Information on the active substances
Informacije o aktivnih snoveh
Information on safeners, synergists and co-formulants
Informacije o varovalih, sinergistih in dodatkih
Type and code of the plant protection product
Vrsta in šifra fitofarmacevtskega sredstva
Explosive and oxidising properties
Eksplozivnost in oksidacijske lastnosti
Acidity/alkalinity and pH value
Kislost/bazičnost in vrednost pH
Relative density and bulk density
Relativna gostota in specifična masa
Storage stability and shelf-life:
Stabilnost med shranjevanjem in rok uporabe:
effects of temperature on technical characteristics of the plant protection product
učinki temperature na tehnične značilnosti fitofarmacevtskega sredstva
Persistent foaming
Obstojno penjenje
Suspensibility, spontaneity of dispersion and dispersion stability
Suspenzibilnost, spontanost disperzije in stabilnost disperzije
Particle size distribution, dust content, attrition and mechanical stability
Razporeditev delcev po velikosti, vsebnost prahu, drobljivost in mehanska stabilnost
Particle size distribution
Razporeditev delcev po velikosti
Dust content
Vsebnost prahu
Attrition
Drobljivost
Hardness and integrity
Trdota in celovitost
Flowability, pourability and dustability
Sipkost, pretočnost, prašljivost
Data on application
Podatki o nanosu
Effects on harmful organisms
Učinki na škodljive organizme
Application rate and concentration of the active substance
Odmerek in koncentracija aktivne snovi
Method of application
Metoda nanašanja
Number and timing of applications and duration of protection
Število in čas nanosov ter trajanje zaščite
Necessary waiting periods or other precautions to avoid phytotoxic effects on succeeding crops
Potrebne karence ali drugi varnostni ukrepi za preprečevanje fitotoksičnih učinkov na naslednje kulture
Safety intervals and other precautions to protect humans, animals and the environment
Karenčne dobe in drugi varnostni ukrepi za zaščito ljudi, živali in okolja
Recommended methods and precautions
Priporočene metode in varnostni ukrepi
Packaging, compatibility of the plant protection product with proposed packaging materials
Embalaža in združljivost fitofarmacevtskega sredstva s predlaganimi embalažnimi materiali
Neutralisation procedures
Postopki nevtralizacije
Methods used for the generation of pre-authorisation data
Metode za pridobivanje podatkov pred registracijo
Methods for the analysis of the plant protection product
Metode za analizo fitofarmacevtskega sredstva
Methods for post-authorisation control and monitoring purposes
Metode za namene nadzora in spremljanja po registraciji
Preliminary tests
Predhodni preskusi
Testing effectiveness
Preskušanje učinkovitosti
Information on the occurrence or possible occurrence of the development of resistance
Informacije o pojavu ali možnem pojavu razvoja odpornosti
Adverse effects on treated crops
Škodljivi učinki na tretirane kulture
Phytotoxicity to target plants (including different cultivars), or to target plant products
Fitotoksičnost za ciljne rastline (vključno z različnimi kultivarji) ali ciljne rastlinske proizvode
Effects on the yield of treated plants or plant products
Učinki na donos tretiranih rastlin ali rastlinskih proizvodov
Effects on the quality of plants or plant product
Učinki na kakovost rastlin ali rastlinskih proizvodov
Effects on transformation processes
Učinki na postopke transformacije
Observations on other undesirable or unintended side-effects
Ugotovitve o drugih neželenih ali nepredvidenih stranskih učinkih
Effects on beneficial and other non-target organisms
Učinki na koristne in druge neciljne organizme
Oral toxicity
Oralna toksičnost
Dermal toxicity
Dermalna toksičnost
Inhalation toxicity
Inhalacijska toksičnost
Supplementary studies on the plant protection product
Dodatne študije o fitofarmacevtskem sredstvu
Supplementary studies for combinations of plant protection products
Dodatne študije za kombinacije fitofarmacevtskih sredstev
Operator exposure
Izpostavljenost izvajalca tretiranja
Measurement of operator exposure
Meritev izpostavljenosti izvajalca tretiranja
Bystander and resident exposure
Izpostavljenost drugih navzočih oseb in prebivalcev
Estimation of bystander and resident exposure
Ocena izpostavljenosti drugih navzočih oseb in prebivalcev
Measurement of bystander and resident exposure
Meritev izpostavljenosti drugih navzočih oseb in prebivalcev
Measurement of worker exposure
Meritev izpostavljenosti delavca
Available toxicological data relating to co-formulants
Razpoložljivi toksikološki podatki o dodatkih
Estimation of concentrations in soil
Ocena koncentracij v tleh
Calculation of concentrations in groundwater
Izračun koncentracij v podtalnici
Additional field tests
Dodatni terenski preskusi
Estimation of concentrations in surface water and sediment
Ocena koncentracij v površinskih vodah in usedlini
Route and rate of degradation in air and transport via air
Pot in stopnja razgradnje v zraku ter prenos po zraku
Estimation of concentrations for other routes of exposure
Ocena koncentracij za druge načine izpostavljenosti
Higher tier data on birds
Podatki o pticah na višji stopnji
Higher tier data on mammals
Podatki o sesalcih na višji stopnji
Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)
Učinki na druge prostoživeče kopenske vretenčarje (plazilci in dvoživke)
Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes
Akutna toksičnost za ribe in vodne nevretenčarje ali učinki na vodne alge in makrofite
Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms
Dodatne študije o dolgotrajni in kronični toksičnosti za ribe, vodne nevretenčarje in organizme, ki živijo v usedlinah
Effects on honey bee development and other honey bee life stages
Učinki na razvoj čebele in njene druge življenjske faze
Cage and tunnel tests
Preskusi v kletki in tunelu
Field tests with honeybees
Terenski preskusi s čebelami
Standard laboratory testing for non-target arthropods
Standardni laboratorijski preskusi za neciljne členonožce
Extended laboratory testing, aged residue studies with non-target arthropods
Razširjeni laboratorijski preskusi, študije o starih ostankih na neciljnih členonožcih
Semi-field studies with non-target arthropods
Študije na neciljnih členonožcih pod kontroliranimi pogoji na prostem
Field studies with non-target arthropods
Terenske študije na neciljnih členonožcih
Other routes of exposure for non-target arthropods
Drugi načini izpostavljenosti za neciljne členonožce
Earthworms
Deževniki
Earthworms — sub-lethal effects
Deževniki – subletalni učinki
Earthworms — field studies
Deževniki – terenske študije
Higher tier testing
Preskusi na višji stopnji
Extended laboratory studies on non-target plants
Razširjene laboratorijske študije na neciljnih rastlinah
Semi-field and field tests on non-target plants
Terenski preskusi in preskusi pod kontroliranimi pogoji na prostem na neciljnih rastlinah
Effects on other terrestrial organisms (flora and fauna)
Učinki na druge kopenske organizme (rastlinske in živalske vrste)
The information provided shall be sufficient to precisely identify the plant protection product and define it in terms of its specification and nature.
Predložene informacije zadoščajo za natančno opredelitev fitofarmacevtskega sredstva ter določitev njegove specifikacije in narave.
Producer of the plant protection product and of the active substances
Proizvajalec fitofarmacevtskega sredstva in aktivnih snovi
The name and address of the producer of the plant protection product and of each active substance in the plant protection product shall be provided, as well as the name and address of each manufacturing plant in which the plant protection product and active substance are manufactured.
Navedejo se ime in naslov proizvajalca fitofarmacevtskega sredstva in posamezne aktivne snovi v fitofarmacevtskem sredstvu ter ime in naslov vseh proizvodnih obratov, v katerih se fitofarmacevtsko sredstvo in aktivna snov proizvajata.
If the active substance originates from a producer from which data in accordance with Regulation (EU) No 283/2013 have not been submitted previously, data to address those requirements shall be provided in order to establish equivalence of the active substance.
Če aktivno snov proizvaja proizvajalec, ki še ni predložil podatkov v skladu z Uredbo (EU) št. 283/2013, se navedejo podatki za izpolnjevanje zadevnih zahtev, da se določi enakovrednost aktivne snovi.
All former and current trade names and proposed trade names and development code numbers of the plant protection product shall be provided.
Navedejo se vsa prejšnja in sedanja trgovska imena, predlagana trgovska imena in razvojne šifre fitofarmacevtskega sredstva.
Where trade names and code numbers referred to, relate to similar but different plant protection products, full details of the differences shall be provided.
Kadar se navedena trgovska imena in šifre nanašajo na podobna, vendar različna fitofarmacevtska sredstva, se navedejo vse podrobnosti teh razlik.
The proposed trade name shall be such that it does not give rise to confusion with the trade name of already authorised plant protection products.
Predlagano trgovsko mora biti takšno, da ne povzroča zmede zaradi zamenjave s trgovskim imenom že registriranih fitofarmacevtskih sredstev.
Each code number shall be specific to a unique plant protection product.
Vsako fitofarmacevtsko sredstvo ima posebno šifro.
For plant protection products the following information shall be reported:
Za fitofarmacevtska sredstva se navedejo naslednje informacije:
the content of the technical active substances (based on the specified minimum purity) and the declared content of pure active substances and, where relevant, the corresponding content of the variant (such as salts and esters) of the active substances,
vsebnost tehničnih aktivnih snovi (glede na določeno minimalno čistost) in navedena vsebnost čistih aktivnih snovi ter, kadar je ustrezno, ustrezna vsebnost variante (kot so soli in estri) aktivnih snovi,
the content of safeners, synergists and co-formulants,
vsebnost varoval, sinergistov in dodatkov,
the maximum content of relevant impurities, where appropriate.
največja vsebnost relevantnih nečistoč, kadar je primerno.
In addition to the total active substance content, for slow or controlled release plant protection products (such as capsule suspension, CS) the free (non-encapsulated) and encapsulated active substance content and the release rate shall be given.
Poleg skupne vsebnosti aktivnih snovi se za fitofarmacevtska sredstva, ki se počasi ali nadzorovano sproščajo (na primer suspenzija v kapsulah), navedeta vsebnost proste (neinkapsulirane) in inkapsulirane aktivne snovi ter stopnja sproščanja.
Where possible, appropriate Collaborative International Pesticides Analytical Council (CIPAC) methods shall be used.
Kadar je to mogoče, se uporabijo ustrezne metode Kolaborativnega mednarodnega sveta za analizo pesticidov (CIPAC).
If an alternative method is used this shall be justified by the applicant and a detailed description of the methodology used shall be given.
Če se uporabi druga metoda, jo vlagatelj utemelji in predloži podroben opis uporabljene metodologije.
The concentration of each active substance shall be expressed as follows:
Koncentracija posamezne aktivne snovi se izrazi na naslednji način:
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 % m/m in g/kg,
for other liquids/gel formulations, as % w/w and g/l,
za druge tekočine/formulacije v obliki gela kot % m/m in g/l,
for gases, as % v/v and % w/w.
za pline kot % v/v in % m/m.