natgillin/translations-raw huggingface dataset:
The title ‘Uniform Principles for evaluation and authorisation of plant protection products’ shall be replaced by
naslov „Enotna načela za ocenjevanje in registracijo fitofarmacevtskih sredstev“ se nadomesti z naslednjim:
‘PART I
„DEL I
UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF CHEMICAL PLANT PROTECTION PRODUCTS’;
ENOTNA NAČELA ZA OCENJEVANJE IN REGISTRACIJO KEMIČNIH FITOFARMACEVTSKIH SREDSTEV“;
The following Part shall be added after Part I
za delom I se doda naslednji del:
UNIFORM PRINCIPLES FOR EVALUATION AND AUTHORISATION OF PLANT PROTECTION PRODUCTS CONTAINING MICRO-ORGANISMS’
ENOTNA NAČELA ZA OCENJEVANJE IN REGISTRACIJO FITOFARMACEVTSKIH SREDSTEV, KI VSEBUJEJO MIKROORGANIZME“
EVALUATION
OCENJEVANJE
Specific principles
Posebna načela
Identity
Identiteta
Identity of the micro-organism in the plant protection product
Identiteta mikroorganizma v fitofarmacevtskem sredstvu
Identity of the plant protection product
Identiteta fitofarmacevtskega sredstva
Biological, physical, chemical and technical properties
Biološke, fizikalne, kemijske in tehnične lastnosti
Biological properties of the micro-organism in the plant protection product
Biološke lastnosti mikroorganizma v fitofarmacevtskem sredstvu
Physical, chemical and technical properties of the plant protection product
Fizikalne, kemijske in tehnične lastnosti fitofarmacevtskega sredstva
Quality control of the production of the micro-organism in the plant protection product
Nadzor kakovosti produkcije mikroorganizma v fitofarmacevtskem sredstvu
Quality control of the plant protection product
Kontrola kakovosti fitofarmacevtskega sredstva
Identification/detection and quantification methods
Metode določanja/odkrivanja in količinskega opredeljevanja
Analytical methods for the plant protection product
Analitske metode za fitofarmacevtsko sredstvo
Analytical methods for the determination of residues
Analitske metode za določanje ostankov
Impact on human and animal health
Vpliv na zdravje ljudi in živali
Effects on human or animal health arising from the plant protection product
Učinki na zdravje ljudi ali živali, ki izhajajo iz fitofarmacevtskega sredstva
Effects on human or animal health arising from residues
Učinki ostankov na zdravje ljudi ali živali, ki izhajajo iz fitofarmacevtskega sredstva
Fate and behaviour in the environment
Obstanek in obnašanje v okolju
Effects on and exposure of non-target organisms
Učinki na neciljne organizme in njihova izpostavljenost
Conclusions and proposals
Zaključki in predlogi
DECISION-MAKING
ODLOČANJE
Biological and technical properties
Biološke in tehnične lastnosti
Effects on non-target organisms
Učinki na neciljne organizme
The principles developed in Part II of this Annex 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 4(1)(b), (c), (d) and (e) of this Directive by all Member States at a high level of protection of human and animal health and the environment.
Cilj načel, natančno obrazloženih v delu II te priloge, je zagotoviti, da so ocene in odločitve glede registracije fitofarmacevtskih sredstev, če gre za fitofarmacevtska sredstva na osnovi mikroorganizmov, posledica izvajanja zahtev člena 4(1)(b), (c), (d) in (e) te direktive v vseh državah članicah na visoki ravni varovanja zdravja ljudi in živali ter varstva okolja.
In evaluating applications for granting authorisations Member States shall:
Države članice pri oceni zahtevkov za odobritev registracij:
ensure that dossiers on microbial plant protection products supplied are in accordance with the requirements of Annex IIIB, at the latest at the time of finalisation of the evaluation for the purpose of decision-making, without prejudice, where relevant, to the provisions of Article 13(1)(a), (4) and (6) of this Directive,
zagotovijo, da je predložena dokumentacija o fitofarmacevtskih sredstvih na osnovi mikroorganizmov v skladu z zahtevami iz Priloge IIIB najpozneje do dokončnega izoblikovanja ocene zaradi odločanja, brez poseganja, kadar je ustrezno, v določbe člena 13(1)(a), (4) in (6) te direktive,
ensure that the data submitted are acceptable in terms of quantity, quality, consistency and reliability and sufficient to permit a proper evaluation of the dossier,
zagotovijo, da so predloženi podatki sprejemljivi glede količine, kakovosti, doslednosti in zanesljivosti ter primerni za pravilno oceno dokumentacije,
evaluate, where relevant, justifications submitted by the applicant for not supplying certain data;
ocenijo, kadar je ustrezno, utemeljitev vlagatelja glede manjkajočih podatkov;
take into account the Annex IIB data concerning the active substance consisting of micro-organisms (including viruses) in the plant protection product, submitted for the purpose of inclusion of the micro-organism concerned in Annex I, and the results of the evaluation of those data, without prejudice, where relevant, to the provisions of Article 13(1)(b), (2), (3) and (6) of this Directive;
upoštevajo podatke iz Priloge IIB o aktivni snovi, ki vsebuje mikroorganizme (vključno z virusi) v fitofarmacevtskem sredstvu, ki se predložijo zaradi vključitve zadevnega mikroorganizma v Prilogo I, ter rezultate ocene teh podatkov brez poseganja, kadar je ustrezno, v določbe člena 13(1)(b), (2), (3) in (6) te direktive;
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 ustrezne tehnične ali znanstvene informacije, s katerimi verjetno razpolagajo, v zvezi z delovanjem fitofarmacevtskega sredstva ali morebitnimi škodljivimi učinki fitofarmacevtskega sredstva, njegovih sestavin ali metabolitov/toksinov.
Where, in the specific principles on evaluation, reference is made to Annex IIB data, this shall be understood as being the data referred to in point 2(b).
Kadar se posebna načela za ocenjevanje sklicujejo na podatke iz Priloge IIB, se to šteje kot sklicevanje na podatke iz točke 2(b).
Where the data and information provided are sufficient to permit completion of the evaluation for one of the proposed uses, applications must be evaluated and a decision made for the proposed use.
Kadar je predloženih dovolj podatkov in informacij za dokončno oblikovanje ocene za eno od predlaganih uporab, je zahtevke treba oceniti in sprejeti odločitev za predlagano uporabo.
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 zahtevke, pri katerih manjka toliko podatkov, da ocene ni mogoče dokončno oblikovati in sprejeti zanesljive odločitve vsaj za 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 this Directive.
Med postopkom ocenjevanja in odločanja država članica sodeluje z vlagatelji zahtevkov, da lahko hitreje rešuje vprašanja v zvezi z dokumentacijo ali da na začetni stopnji določi vse dodatne študije, potrebne za pravilno oceno dokumentacije, ali da spremeni katere koli predlagane pogoje uporabe fitofarmacevtskega sredstva ali njegovo lastnost ali sestavo, s čimer v celoti zagotovi izpolnjevanje zahtev iz te priloge ali te direktive.
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 prejetju tehnično popolne dokumentacije.
A technically complete dossier is one that satisfies all the requirements of Annex IIIB.
Tehnično popolna dokumentacija mora izpolnjevati vse zahteve iz Priloge IIIB.
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 postopkom ocenjevanja in odločanja, morajo temeljiti na znanstvenih načelih, po možnosti priznanih na mednarodni ravni, oblikovanih ob podpori strokovnih nasvetov.
A microbial plant protection product may contain viable and non-viable micro-organisms (including viruses) and formulation substances.
Fitofarmacevtsko sredstvo na osnovi mikroorganizmov 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 pomembne 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, pomembne metabolite/toksine in 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 prehransko verigo in zdravstveno varstvo živali (SCFCAH).
For genetically modified micro-organisms, Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms, must be taken into account.
Pri gensko spremenjenih mikroorganizmih je treba upoštevati Direktivo 2001/18/ES Evropskega parlamenta in Sveta z dne 12. marca 2001 o namernem sproščanju gensko spremenjenih organizmov v okolje.
The evaluation completed in the framework of that Directive must be provided and taken into account.
V okviru te direktive dokončno oblikovano oceno je treba dati in jo je treba upoštevati.
Definitions and explanations of microbiological terms
Opredelitev in obrazložitev mikrobioloških pojmov
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 ogrožujoča 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 ki očitno 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).
Antimikrobiološki: antimikrobiološka sredstva so naravno navzoče, polsintetične snovi ali sintetične snovi, ki delujejo antimikrobiološko (ubijajo mikroorganizme ali zavirajo njihovo rast).
The term ‘Antimicrobial(s)’ includes:antibiotics, which refer to substances produced by or derived from micro-organisms, and
Pojem antimikrobiološko(-a) sredstvo(-a) vključuje: 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.
antikokcidialna sredstva, to so snovi, ki učinkujejo proti kokcidijem, enoceličnim parazitom protoze.
CFU: Colony-forming unit; one or more cells that grow to form a single visible colony.
CFU: enota, ki tvori kolonijo; ena ali več rastočih celic, ki tvorijo 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 obstoj mikroorganizmov v okolju, kakršna je zunanja (koža) ali notranja telesna površina (črevesje, pljuča).
For colonisation, the micro-organism should at least persist for a longer period than expected in a specific organ.
Pri kolonizaciji naj bi mikroorganizem vztrajal v določenem organu vsaj dlje časa, kakor 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 kakor pri običajem odstranjevanju; populacija je lahko stabilna, lahko pa je tudi rastoča.
Colonisation can be related to harmless and functional micro-organisms as well as to pathogenic micro-organisms.
Kolonizacija je lahko povezana z neškodljivimi in funkcionalnimi mikroorganizmi ali pa s patogenimi mikroorganizmi.
The possible occurrence of effects is not indicated.
Možno pojavljanje učinkov ni navedeno.
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, v smislu dejansko zavzetega fizičnega prostora in funkcije, ki jo opravlja v združbi 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 soj 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 učinek na enega 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 škodljiv učinek na širok izbor različnih gostiteljev.
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 sposoben razmnoževati se, da tvori nove kužne enote.
Simply ingesting a pathogen does not imply infection.
Zaužitje patogena še ni okužba.
Infective: Capable of transmitting an infection.
Kužen: sposoben prenašati okužbo.
Infectivity: The characteristics of a micro-organism that allow it to infect a susceptible host.
Infektivnost: 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: sposobnost mikroorganizmov za razmnoževanje in številčno rast med okužbo.
Mycotoxin: A fungal toxin.
Mikotoksin: toksin nekaterih gliv in plesni.
Non-viable micro-organism: A micro-organism that is not capable of replication or of transferring genetic material.
Neaktivni mikroorganizem: mikroorganizem, ki se ni sposoben razmnoževati ali ni sposoben 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 sposoben razmnoževati ali ni sposoben prenašati genskega materiala.
Pathogenicity: The ability of a micro-organism to cause disease and/or inflict damage on the host.
Patogenost: sposobnost mikrorganizma, 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 sposobnosti 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/ki drug brez drugega ne moreta živeti, 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 sposoben razmnoževati ali prenašati genski material.
Viable residue: A residue that is capable of replication or of transferring genetic material.
Aktivni ostanek: ostanek, ki se je sposoben razmnoževati ali je sposoben prenašati genski material.
Viroid: Any of a class of infectious agents consisting of a small strand of RNA not associated with any protein.
Viroid: kateri koli iz razreda povzročiteljev okužb s kratko golo enojnoverižno RNA, ki ni povezan z nobenim proteinom.
The RNA does not code for proteins and is not translated; it is replicated by host cell enzymes.
RNA ne kodira proteinov in ni prevedena; množi se s celičnimi encimi gostitelja.
Viroids are known to cause several plant diseases.
Viroidi povzročajo več bolezni pri rastlinah.
Virulence: Measurement of the degree of disease producing ability of a micro-organism as indicated by the severity of the disease produced.
Virulenca: stopnja zmožnosti mikroorganizma povzročiti bolezen, ki se izraža z resnostjo povzročene bolezni.
Measure of the dosage (inoculum size) required to cause a specific degree of pathogenicity.
Merilna enota potrebnega odmerka (velikost cepiva), ki povzroči neko stopnjo patogenosti.
It is measured experimentally by the median lethal dose (LD50) or median infective dose (ID50).
Meri se poskusno s srednjo vrednostjo smrtnega odmerka (LD50) ali srednjo vrednostjo infektivnega odmerka (ID50).
The objective of an evaluation is to identify and assess, on a scientific basis and until further experience is reached on a case-by-case basis, potential adverse effects on human and animal health and the environment of the use of a microbial plant protection product.
Cilj ocenjevanja je, da se na znanstveni podlagi in dokler se ne pridobijo dodatne izkušnje na osnovi posamičnih primerov, določijo in ocenijo možni škodljivi učinki na zdravje ljudi in živali ter na okolje zaradi uporabe fitofarmacevtskega sredstva na osnovi mikroorganizmov.
The evaluation shall also be carried out in order to identify the need for risk management measures and to identify and recommend suitable measures.
Ocenjevanje se izvede tudi zaradi določitve potrebe po ukrepih za obvladovanje tveganja ter da se določijo in priporočijo ustrezni ukrepi.
Due to the ability of micro-organisms to replicate, there is a clear difference between chemicals and micro-organisms used as plant protection products.
Zaradi sposobnosti mikroorganizmov, da se razmnožujejo, je jasna razlika med kemikalijami in mikroorganizmi, ki se uporabljajo kot fitofarmacevtska sredstva.
Hazards arising are not necessarily of the same nature as those presented by chemicals, especially in relation to the capacity of micro-organisms to persist and multiply in different environments.
Nevarnosti, ki iz tega izvirajo, niso nujno iste vrste kakor nevarnosti, ki jih predstavljajo kemikalije, zlasti glede na sposobnost mikroorganizmov, da so obstojni in se množijo v različnem okolju.
Moreover, micro-organisms consist of a wide range of different organisms, all with their own unique characteristics.
Mikroorganizme sestavlja veliko različnih organizmov, ki imajo vsak sebi lastne lastnosti.
These differences between micro-organisms should be taken into account in the evaluation.
Pri ocenjevanju je razlike med mikroorganizmi treba upoštevati.
The micro-organism in the plant protection product should ideally function as a cell factory working directly on the spot where the target organism is harmful.
Mikroorganizem v fitofarmacevtskem sredstvu naj bi v idealnih razmerah deloval kot tovarna celic, ki deluje neposredno na mesto škodljivega delovanja ciljnega organizma.
Thus understanding the mode of action is a crucial step in the evaluation process.
Zato je razumevanje načina delovanja ključna faza v postopku ocenjevanja.
Micro-organisms may produce a range of different metabolites (e.g. bacterial toxins or mycotoxins) many of which may have toxicological significance, and one or more of which may be involved in the mode of action of the plant protection product.
Mikroorganizmi lahko proizvajajo vrsto različnih metabolitov (npr. bakterijske toksine ali mikotoksine), od katerih so številni toksikološko pomembni, eden ali več pa jih je lahko vključenih v način delovanja fitofarmacevtskega sredstva.
The characterisation and identification of relevant metabolites should be assessed and the toxicity of these metabolites should be addressed.
Oceniti je treba značilnosti in identifikacijo pomembnih metabolitov in obravnavati njihovo toksičnost.
Information on production and/or relevance of metabolites may be deduced from:(a) toxicity studies,
Informacije o produkciji in/ali pomembnosti metabolitov se lahko povzamejo iz:(a) študij toksičnosti;
biological properties of the micro-organism,
bioloških lastnosti mikroorganizma;
relationship to known plant, animal or human pathogens,
odnosa do znanih rastlinskih, živalskih ali človeških patogenov;
mode of action,
načina delovanja;
analytical methods.
analitskih metod.
On the basis of this information, metabolites may be considered as possibly being relevant.
Na podlagi navedenih informacij se metaboliti lahko štejejo za možno pomembne.
Therefore potential exposure to these metabolites should be assessed, in order to decide on their relevance.
Pri odločitvi, kako pomembni so, je treba oceniti potencialno izpostavljenost tem metabolitom.
Having regard to current scientific and technical knowledge, Member States shall evaluate the information provided in accordance with the requirements of Annex IIB and IIIB and in particular:
Ob upoštevanju zdajšnjih znanstvenih in tehničnih dognanj države članice ocenijo informacije, predložene v skladu z zahtevami iz prilog IIB in IIIB, in zlasti:
identify the hazards arising, assess their significance and make a judgement as to the likely risks to humans, animals or the environment; and
opredelijo nevarnosti, ki jih predstavlja fitofarmacevtsko sredstvo, ocenijo pomembnost teh nevarnosti in presodijo o verjetnem tveganju pri ljudeh, živalih ali v okolju; ter