natgillin/translations-raw huggingface dataset:
unless it is clearly established through an appropriate risk assessment that under field conditions no unacceptable impact on the viability of exposed species (predators) occurs — directly or indirectly — after use of the plant protection product in accordance with the proposed conditions of use.
razen če se z ustrezno oceno tveganja jasno dokaže, da uporaba fitofarmacevtskega sredstva v terenskih razmerah predvidene uporabe nima nesprejemljivega – posrednega ali neposrednega – vpliva na preživetje in razvoj izpostavljenih vrst (plenilcev).
Where there is a possibility of honeybees being exposed, no authorisation shall be granted if the hazard quotients for oral or contact exposure of honeybees are greater than 50, unless it is clearly established through an appropriate risk assessment that under field conditions there are no unacceptable effects on honeybee larvae, honeybee behaviour, or colony survival and development after use of the plant protection product in accordance with the proposed conditions of use.
Kadar obstaja možnost izpostavljenosti medonosnih čebel, se registracija ne odobri, če so količniki nevarnosti za oralno ali kontaktno izpostavljenost čebel večji od 50, razen če se z ustrezno oceno tveganja jasno dokaže, da uporaba fitofarmacevtskega sredstva v terenskih razmerah predlagane uporabe nima nesprejemljivega vpliva na ličinke čebel, vedenje čebel ali preživetje in razvoj družine.
Where there is a possibility of beneficial arthropods other than honeybees being exposed, no authorisation shall be granted if more than 30 % of the test organisms are affected in lethal or sublethal laboratory tests conducted at the maximum proposed application rate, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on those organisms after use of the plant protection product in accordance with the proposed conditions of use.
Kadar obstaja možnost izpostavljenosti drugih koristnih členonožcev razen medonosnih čebel se registracija ne odobri, če je v letalnih in subletalnih laboratorijskih testih, izvedenih pri največjem predlaganem odmerku fitofarmacevtskega sredstva, prizadetih več kot 30 % testnih organizmov, razen če se z ustrezno oceno tveganja jasno dokaže, da uporaba fitofarmacevtskega sredstva v terenskih razmerah predlagane uporabe nima nesprejemljivega vpliva na navedene organizme.
Where there is a possibility of earthworms being exposed, no authorisation shall be granted if the acute toxicity/exposure ratio for earthworms is less than 10 or the long-term toxicity/exposure ratio is less than 5, unless it is clearly established through an appropriate risk assessment that under field conditions earthworm populations are not at risk after use of the plant protection product in accordance with the proposed conditions of use.
Kadar obstaja možnost izpostavljenosti deževnikov, se registracija ne odobri, če je razmerje med akutno toksičnostjo in izpostavljenostjo deževnikov manjše od 10 ali je razmerje med dolgotrajno toksičnostjo in izpostavljenostjo manjše od 5, razen če se z ustrezno oceno tveganja jasno dokaže, da uporaba fitofarmacevtskega sredstva v terenskih razmerah predlagane uporabe nima nesprejemljivega vpliva na populacije deževnikov.
Where there is a possibility of non-target soil micro-organisms being exposed, no authorisation shall be granted if the nitrogen or carbon mineralisation processes in laboratory studies are affected by more than 25 % after 100 days, unless it is clearly established through an appropriate risk assessment that under field conditions there is no unacceptable impact on microbial activity after use of the plant protection product in accordance with the proposed conditions of use, taking account of the ability of micro-organisms to multiply.
Kadar obstaja možnost izpostavljenosti neciljnih talnih mikroorganizmov, se registracija ne odobri, če se proces mineralizacije dušika ali ogljika med laboratorijskimi študijami po 100 dneh spremeni za več kot 25 %, razen če se z ustrezno oceno tveganja jasno dokaže, da uporaba fitofarmacevtskega sredstva v terenskih razmerah predlagane uporabe nima nesprejemljivega vpliva na mikrobiološko aktivnost ob upoštevanju zmožnosti mikroorganizmov za razmnoževanje.
The methods proposed must reflect the state of the article.
Predlagane metode morajo odražati dejansko stanje.
The following criteria must be met in order to permit validation of the analytical methods proposed for post-registration control and monitoring purposes:
Za validacijo predlaganih analitskih metod za spremljanje in nadzor po registraciji fitofarmacevtskega sredstva je treba izpolniti naslednja merila:
the method must be able to determine and to identify the active substance(s) and where appropriate any toxicologically, ecotoxicologically or environmentally significant impurities and co-formulants;
metoda mora omogočati določitev in opredelitev aktivnih snovi, ter kadar je ustrezno, vseh toksikološko, ekotoksikološko ali okoljsko pomembnih nečistoč in pomožnih snovi v formulaciji;
the method must be able to determine and confirm residues of toxicological, ecotoxicological or environmental significance;
metoda mora omogočati določitev in potrditev ostankov, ki imajo toksikološki, ekotoksikološki ali okoljski pomen;
the mean recovery rates should be between 70 % and 110 % with a relative standard deviation of ≤ 20 %;
povprečna stopnja primerljivosti rezultatov pri ponovitvi analize mora biti od 70 % do 110 %, z relativno standardno deviacijo ≤ 20 %;
the repeatability must be less than the following values for residues in foodstuffs:
razlika pri ponovljivosti metode mora biti manjša od naslednjih vrednosti za ostanke v živilih:
Residue level
Vrednost ostankov
Intermediate values shall be determined by interpolation from a log-log graph;
Vmesne vrednosti se določijo z interpolacijo iz grafa log-log;
the reproducibility must be less than the following values for residues in foodstuffs:
razlika pri reproduktivnosti (posnemalnosti) mora biti manjša od naslednjih vrednosti za ostanke v živilih:
Intermediate values are determined by interpolation from a log-log graph;
Vmesne vrednosti se določijo z interpolacijo iz grafa log-log;
in the case of residue analysis in treated plants, plant products, foodstuffs, feedingstuffs or products of animal origin, except where the MRL or the proposed MRL is at the limit of determination, the sensitivity of the methods proposed must satisfy the following criteria:
pri analizi ostankov fitofarmacevtskega sredstva v tretiranih rastlinah, rastlinskih proizvodih, živilih, krmi ali proizvodih živalskega izvora, razen kadar je mejna vrednost ostankov ali predlagana mejna vrednost ostankov na meji določitve, mora občutljivost predlaganih metod izpolnjevati naslednja merila:
Limit of determination in relation to the proposed provisional or EU MRL:
meja določitve glede na predlagane začasne mejne vrednosti ostankov ali mejne vrednosti ostankov v EU:
limit of determination
Meja določitve
Where an appropriate FAO specification exists, that specification must be met.
Kadar obstaja ustrezna specifikacija FAO, ji mora specifikacija ustrezati.
Where no appropriate FAO specification exists, the physical and chemical properties of the product must meet the following requirements
Kadar ni ustrezne specifikacije FAO, morajo fizikalne in kemijske lastnosti sredstva izpolnjevati naslednje zahteve:
Chemical properties:
kemijske lastnosti:
Throughout the shelf-life period, the difference between the stated and the actual content of the active substance in the plant protection product must not exceed the following values:
ves rok trajanja razlika med deklarirano in dejansko vsebnostjo aktivne snovi v fitofarmacevtskem sredstvu ne sme presegati naslednjih vrednosti:
Declared content in g/kg or g/l at 20 °C
Deklarirana vsebnost v g/kg ali g/l pri 20 °C
Tolerance
Toleranca
± 15 % homogeneous formulation
± 15 % homogene formulacije
± 25 % non-homogeneous formulation
± 25 % nehomogene formulacije
more than 25 up to 100
več kot 25 do 100
more than 100 up to 250
več kot 100 do 250
more than 250 up to 500
več kot 250 do 500
more than 500
več kot 500
± 25 g/kg or ± 25 g/l
± 25 g/kg ali ± 25 g/l
Physical properties:
fizikalne lastnosti:
The plant protection product must fulfil the physical criteria (including storage stability) specified for the relevant formulation type in the ‘Manual on the development and use of FAO and WHO specifications for plant protection products’.
fitofarmacevtsko sredstvo mora izpolnjevati fizikalna merila (vključno s stabilnostjo pri skladiščenju) za ustrezen tip formulacije, predpisana v „Priročniku za razvoj in uporabo FAO in SZO specifikacij za fitofarmacevtska sredstva“.
Where the proposed label claims include requirements or recommendations for use of the preparation with other plant protection products or adjuvants as a tank mix and/or where the proposed label includes indications on the compatibility of the preparation with other plant protection products as a tank mix, those products or adjuvants must be physically and chemically compatible in the tank mix.
Kadar se na predlagani oznaki zahteva ali priporoča uporaba fitofarmacevtskega sredstva z drugimi fitofarmacevtskimi sredstvi ali dodatki v mešanici v tanku škropilnice in/ali kadar predlagana oznaka navaja združljivost pripravka z drugimi fitofarmacevtskimi sredstvi v mešanici v tanku škropilnice, je treba navesti fitofarmacevtska sredstva ali dodatke fizikalno in kemijsko združljivi v mešanici v tanku škropilnice.
Uniform principles for evaluation and authorisation of plant protection products containing micro-organisms
Enotna načela za ocenjevanje in registracijo fitofarmacevtskih sredstev, ki vsebujejo mikroorganizme
Quality control of the plant protection product
Nadzor kakovosti fitofarmacevtskega sredstva
Effects on human or animal health arising from residues
Učinki ostankov na zdravje ljudi ali živali
Conclusions and proposals
Sklepi in predlogi
The principles developed in Part II aim to ensure that evaluations and decisions with regard to authorisation of plant protection products, provided they are microbial plant protection products, result in the implementation of the requirements of Article 29(1)(e) in conjunction with Article 4(3) and Article 29(f), (g) and (h) of Regulation (EC) No 1107/2009 by all Member States at a high level of protection of human and animal health and the environment.
Cilj načel iz dela II je zagotoviti, da se z ocenjevanjem in odločanjem glede registracije fitofarmacevtskih sredstev, če so to mikrobiološka fitofarmacevtska sredstva, izvajajo zahteve člena 29(1)(e) skupaj s členom 4(3), členom 29(f), (g) in (h) Uredbe (ES) št. 1107/2009 v vseh državah članicah na visoki ravni varovanja zdravja ljudi, živali in okolja.
In evaluating applications for granting authorisations Member States shall:
Države članice pri ocenjevanju vlog in izdaji registracij:
ensure that dossiers on microbial plant protection products supplied are in accordance with the requirements of part B of the Annex to Regulation (EU) No 545/2011, at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to Articles 33, 34 and 59 of Regulation (EC) No 1107/2009,
zagotovijo, da se najpozneje do dokončanja ocene za namene odločanja predloži dokumentacija o mikrobiološkem fitofarmacevtskem sredstvu, ki je v skladu z zahtevami dela B Priloge k Uredbi Komisije (EU) št. 545/2011, brez poseganja, kadar je to relevantno, v določbe členov 33, 34 in 59 Uredbe (ES) št. 1107/2009,
take into account the data referred to in part B of the Annex to Regulation (EU) No 544/2011, concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of approval of the micro-organism concerned as active substances under Regulation (EC) No 1107/2009, and the results of the evaluation of those data, without prejudice, where relevant, to Article 33(3) and Articles 34 and 59 of Regulation (EC) No 1107/2009;
upoštevajo podatke iz dela B Priloge k Uredbi Komisije (EU) št. 544/2011 o aktivni snovi, ki vsebuje mikroorganizme (vključno z virusi), v fitofarmacevtskem sredstvu, ki so bili predloženi za namen odobritve zadevnega mikroorganizma kot aktivne snovi v skladu z Uredbo (ES) št. 1107/2009, in oceno navedenih podatkov, brez poseganja, kadar je to relevantno, v določbe člena 33(3) ter členov 34 in 59 Uredbe (ES) št. 1107/2009;
take into consideration other relevant technical or scientific information they can reasonably possess with regard to the performance of the plant protection product or to the potentially adverse effects of the plant protection product, its components or its metabolites/toxins.
upoštevajo druge relevantne tehnične ali znanstvene informacije, s katerimi verjetno razpolagajo, o delovanju fitofarmacevtskega sredstva ali morebitnih škodljivih učinkih fitofarmacevtskega sredstva, njegovih sestavin ali metabolitov/toksinov.
Where, in the specific principles on evaluation, reference is made to the data of part B of the Annex to Regulation (EU) No 544/2011 this shall be understood as being the data referred to in point 2(b).
Kadar se posebna načela za ocenjevanje sklicujejo na podatke iz dela B Priloge k Uredbi Komisije (EU) št. 544/2011, se to razume kot podatki iz točke 2(b).
Taking account of justifications provided and with the benefit of any subsequent clarifications, Member States shall reject applications for granting authorisations for which the data gaps are such that it is not possible to finalise the evaluation and to make a reliable decision for at least one of the proposed uses.
Države članice ob upoštevanju predloženih utemeljitev in morebitnih poznejših pojasnil zavrnejo vloge, pri katerih manjka toliko podatkov, da ni mogoče dokončati ocenjevanja in sprejeti zanesljive odločitve za vsaj eno od predlaganih uporab.
During the process of evaluation and decision-making, the Member State shall cooperate with the applicants in order to resolve any questions on the dossier quickly or to identify at an early stage any additional studies necessary for a proper evaluation of the dossier, or to amend any proposed conditions for the use of the plant protection product or to modify its nature or its composition in order to ensure full satisfaction of the requirements of this Annex or of Regulation (EC) No 1107/2009.
Države članice med ocenjevanjem in odločanjem sodelujejo z vlagatelji, da lahko hitro dobijo odgovore na vprašanja o dokumentaciji ali da na začetni stopnji opredelijo vse dodatne študije, potrebne za pravilno oceno dokumentacije, ali da spremenijo kakršne koli predlagane pogoje uporabe fitofarmacevtskega sredstva ali spremenijo njegovo naravo ali sestavo, da bi zagotovile popolno izpolnitev zahtev iz te priloge k Uredbi (ES) št. 1107/2009.
Member States shall normally come to a reasoned decision within 12 months of receiving a technically complete dossier.
Države članice načeloma sprejmejo utemeljeno odločitev v 12 mesecih po prejemu tehnično popolne dokumentacije.
A technically complete dossier is one that satisfies all the requirements of part B of the Annex to Regulation (EU) No 545/2011.
Tehnično popolna dokumentacija izpolnjuje vse zahteve iz dela B Priloge k Uredbi (EU) št. 545/2011.
The judgements made by the competent authorities of the Member States during the evaluation and decision-making process must be based on scientific principles, preferably recognised at international level, and be made with the benefit of expert advice.
Mnenja, ki jih pristojni organi držav članic sprejmejo med ocenjevanjem in odločanjem, morajo temeljiti na znanstvenih načelih, po možnosti priznanih na mednarodni ravni, ter ob upoštevanju strokovnih nasvetov.
A microbial plant protection product may contain viable and non-viable micro-organisms (including viruses) and formulation substances.
Mikrobiološko fitofarmacevtsko sredstvo lahko vsebuje aktivne in neaktivne mikroorganizme (vključno z virusi) in snovi v formulaciji.
It may also contain relevant metabolites/toxins produced during growth, residues from the growth medium, and microbial contaminants.
Vsebuje lahko tudi relevantne metabolite/toksine, ki nastanejo med rastjo, ostanke z rastnega gojišča in mikrobiološke onesnaževalce.
The micro-organism, relevant metabolites/toxins and the plant protection product with residual growth medium and microbial contaminants present must all be evaluated.
Oceniti je treba vse mikroorganizme, relevantne metabolite/toksine, fitofarmacevtska sredstva z ostanki rastnega gojišča in mikrobiološke onesnaževalce.
Member States must take into account those guidance documents taken note of in the Standing Committee on the Food Chain and Animal Health (SCFCAH).
Države članice morajo upoštevati smernice, s katerimi je seznanjen Stalni odbor za prehranjevalno verigo in zdravje živali (SCFCAH).
For genetically modified micro-organisms, Directive 2001/18/EC of the European Parliament and of the Council [11], must be taken into account.
Pri gensko spremenjenih organizmih je treba upoštevati Direktivo 2001/18/ES Evropskega parlamenta in Sveta [11].
The evaluation completed in the framework of that Directive must be provided and taken into account.10.
Oceno, dokončano v okviru navedene direktive, je treba predložiti in upoštevati.10.
Antibiosis A relationship between two or more species in which one species is actively harmed (as by the production of toxins by the harming species).
Antibioza odnos med dvema ali več vrstami, pri katerem je ena vrsta aktivno ogrožena (na primer s toksini, ki jih proizvaja ogrožajoča vrsta).
Antigenic Any substance that, as a result of coming in contact with appropriate cells, induces a state of sensitivity and/or immune responsiveness after a latent period (days to weeks) and which reacts in a demonstrable way with antibodies and/or immune cells of the sensitised subject in vivo or in vitro.
Antigenski vse snovi, ki kot posledica prihajanja v stik z ustreznimi celicami povzročijo stanje občutljivosti in/ali imunske odzivnosti po latentnem obdobju (dnevi ali tedni) in dokazljivo reagirajo na protitelesa in/ali imunske celice senzibiliziranega subjekta in vivo ali in vitro.
Antimicrobial Antimicrobial agents or antimicrobial(s) refer to naturally occurring, semi-synthetic or synthetic substances that exhibit antimicrobial activity (kill or inhibit the growth of micro-organisms).
Protimikrobni protimikrobna sredstva so naravno prisotne, polsintetične snovi ali sintetične snovi, ki delujejo protimikrobno (ubijajo mikroorganizme ali zavirajo njihovo rast).
The term antimicrobial(s) includes:
Pojem protimikrobna sredstva vključuje:
antibiotics, which refer to substances produced by or derived from micro-organisms, and
antibiotike, to so snovi, ki so produkt mikroorganizmov ali so iz njih pridobljene, in
anticoccidials, which refer to substances that are active against coccidia, single cell protozoan parasites.
kokcidiostatike, to so snovi, ki učinkujejo proti kokcidijem, enoceličnim parazitskim praživalim.
CFU Colony-forming unit; one or more cells that grow to form a single visible colony.
CFU enota, ki sestavlja kolonijo; ena ali več rastočih celic, ki sestavljajo eno vidno kolonijo.
Colonisation Proliferation and persistence of a micro-organism in an environment, such as on external (skin) or internal body surfaces (intestine, lungs).
Kolonizacija rast in razmnoževanje ter obstojnost mikroorganizmov v okolju, kot je zunanja (koža) ali notranja telesna površina (črevesje, pljuča).
For colonisation, the micro-organism must at least persist for a longer period than expected in a specific organ.
Pri kolonizaciji se mora mikroorganizem v določenem organu ohraniti vsaj dlje časa, kot se pričakuje.
The population of micro-organisms may decline but at a slower rate than normal clearance; it may be a steady population or it may be a growing population.
Populacija mikroorganizmov se lahko zmanjša, toda počasneje kot pri običajem odstranjevanju; populacija je lahko stabilna, lahko pa je tudi rastoča.
Ecological niche Unique environmental position occupied by a particular species, perceived in terms of actual physical space occupied and function performed within the community or ecosystem.
Ekološka niša edinstveni položaj, ki ga v okolju zavzema neka vrsta kot dejansko zasedeni fizični prostor in funkcija, ki jo opravlja v skupnosti ali ekosistemu.
Host An animal (including humans) or plant that harbours or nourishes another organism (parasite).
Gostitelj žival (vključno s človekom) ali rastlina, ki daje zavetje drugemu organizmu ali ga hrani (parazit).
Host specificity The range of different host-species that can be colonised by a microbial species or strain.
Specifičnost gostitelja niz različnih vrst gostiteljev, ki jih mikrobiološka vrsta ali sev lahko kolonizira.
A host-specific micro-organism colonises or has adverse effects on one or only a small number of different host-species.
Mikroorganizem specifičnega gostitelja kolonizira ali ima škodljiv učinke na enega gostitelja ali samo majhno število različnih gostiteljev.
A non-host-specific micro-organism might colonise or might have adverse effects on a broad range of different host-species.
Mikroorganizem nespecifičnega gostitelja lahko kolonizira ali ima škodljive učinke na številne različne gostitelje.
Infection The introduction or entry of a pathogenic micro-organism into a susceptible host, whether or not it causes pathological effects or disease.
Okužba vdor ali vstop patogenega mikroorganizma v dovzetnega gostitelja, ne glede na to ali ima patološke učinke in ali povzroča bolezen ali ne.
The organism must enter the body of the host, usually the cells, and be able to reproduce to form new infective units.
Organizem mora vstopiti v telo gostitelja, običajno v celice, in mora biti zmožen razmnoževati se v nove kužne enote.
Infective Capable of transmitting an infection.
Kužen zmožen prenašati okužbo.
Infectivity The characteristics of a micro-organism that allow it to infect a susceptible host.
Kužnost lastnost mikroorganizma, ki mu omogoča okužiti dovzetnega gostitelja.
Invasion The entry of a micro-organism into the host body (e.g. actual penetration of the integument, gut epithelial cells, etc.).
Invazija vdor mikroorganizma v telo gostitelja (npr. dejanski prodor skozi povrhnjico, črevesne epitelne celice itn.).
‘Primary invasiveness’ is a property of pathogenic micro-organisms.
„Primarna invazivnost“ je lastnost patogenih mikroorganizmov.
Multiplication Ability of a micro-organism to reproduce and increase in numbers during an infection.
Razmnoževanje zmožnost mikroorganizmov za razmnoževanje in številčno rast med okužbo.
Mycotoxin A fungal toxin.
Mikotoksin toksin nekaterih gliv.
Non-viable micro-organism A micro-organism that is not capable of replication or of transferring genetic material.
Neaktivni mikroorganizem mikroorganizem, ki se ni zmožen razmnoževati ali ni zmožen prenašati genskega materiala.
Non-viable residue A residue that is not capable of replication or of transferring genetic material.
Neaktivni ostanek ostanek, ki se ni zmožen razmnoževati ali ni zmožen prenašati genskega materiala.
Pathogenicity The ability of a micro-organism to cause disease and/or inflict damage on the host.
Patogenost zmožnost mikroorganizma, da povzroči bolezen in/ali poškodbo pri gostitelju.
Many pathogens cause disease by a combination of (i) toxicity and invasiveness or (ii) toxicity and colonising ability.
Številni patogeni povzročijo bolezen s kombinacijo (i) toksičnosti in invazivnosti ali (ii) toksičnosti in zmožnosti kolonizacije.
However, some invasive pathogens cause disease that results from an abnormal reaction of the host’s defence system.
Nekateri invazivni patogeni pa povzročijo bolezen, ki je posledica neobičajne reakcije obrambnega sistema gostitelja.
Symbiosis A type of interaction between organisms where one organism lives in intimate association with another, which is favourable for both organisms.
Simbioza vrsta odnosa med organizmoma, ki živita v tesni povezavi, in je obojestransko koristen.
Viable micro-organism A micro-organism that is capable of replication or of transferring genetic material.
Aktivni mikroorganizem mikroorganizem, ki se je zmožen razmnoževati ali prenašati genski material.