natgillin/translations-raw huggingface dataset:
Testing must be conducted at rates equivalent to the highest rate of field application to be recommended.Test guideline
Test se mora izvesti pri odmerku, ki je enak najvišjemu predlaganemu odmerku za uporabo na terenu.Smernice za testiranje
Where relevant, testing shall be done in accordance with appropriate guidelines which satisfy at least the requirements for testing as included in SETAC — Guidance document on regulatory testing procedures for pesticides with non-target arthropods.
Kadar je to relevantno, se testiranje opravi v skladu z ustreznimi smernicami, ki izpolnjujejo vsaj zahteve za testiranje iz SETAC – Smernice za predpisane testne postopke za pesticide pri neciljnih členonožcih.
The test shall provide the LC50 value of the active substance to earthworms, where possible the highest concentration causing no mortality and the lowest concentration causing 100 % mortality, and must include observed morphological and behavioural effects.
Test zagotovi podatke o vrednosti LC50 aktivne snovi za deževnike in, kadar je to mogoče, najvišjo koncentracijo, ki ne povzroča smrtnosti, in najnižjo koncentracijo, ki povzroča 100 % smrtnost, ter mora vključevati vse opažene vplive na njihovo morfologijo in vedenje.
Effects on earthworms must be investigated, where preparations containing the active substance are applied to soil, or can contaminate soil.
Vplive na deževnike je treba raziskati, kadar so pripravki, ki vsebujejo aktivno snov, namenjeni tretiranju tal ali jih lahko kontaminirajo.
The test must be carried out in accordance with Annex to Regulation (EC) No 440/2008, Method C 8, Toxicity for earthworms: Artificial soil test.
Test je treba izvesti v skladu z metodo C8 iz Priloge k Uredbi (ES) št. 440/2008, Toksičnost za deževnike: Test z umetnim vzorcem tal.
Sublethal effects
Subletalni vpliv
The test shall provide the NOEC and the effects on growth, reproduction and behaviour.
Test zagotovi podatke o vrednostih NOEC in učinkih na rast, razmnoževanje in vedenje.
Where on the basis of the proposed manner of use of preparations containing the active substance or on the basis of its fate and behaviour in soil (DT90 > 100 days), continued or repeated exposure of earthworms to the active substance, or to significant quantities of metabolites, degradation or reaction products, can be anticipated expert judgement is required to decide whether a sublethal test can be useful.
Kadar je na podlagi predlaganega načina uporabe pripravkov, ki vsebujejo aktivno snov, končnega stanja in obnašanja v tleh (DT90 > 100 dni) mogoče predvideti trajno ali ponavljajočo se izpostavljenost deževnikov aktivni snovi, znatnim količinam metabolitov, razgradnih ali reakcijskih produktov, je za odločitev o uporabnosti subletalnega testa potrebna strokovna ocena.
The test must be carried out on Eisenia foetida.
Test je treba opraviti na vrsti Eisenia foetida.
Effects on soil non-target micro-organisms
Vplivi na neciljne talne mikroorganizme
The test shall provide sufficient data to evaluate the impact of the active substance on soil microbial activity, in terms of nitrogen transformation and carbon mineralisation.
Test zagotovi dovolj podatkov za oceno vpliva aktivne snovi na aktivnost talnih mikroorganizmov pri preobrazbi dušika in mineralizaciji ogljika.
The test must be carried out where preparations containing the active substance are applied to soil or can contaminate soil under practical conditions of use.
Test je treba opraviti, kadar so pripravki, ki vsebujejo aktivno snov, namenjeni za tretiranje tal ali lahko v dejanskih pogojih uporabe tla kontaminirajo.
In the case of active substances intended for use in preparations for soil sterilisation, the studies must be designed to measure rates of recovery following treatment.
Če so aktivne snovi namenjene uporabi v pripravkih za razkuževanje tal, je treba študije načrtovati tako, da se merijo hitrosti obnavljanja aktivnosti po tretiranju.
Soils used must be freshly sampled agricultural soils.
Vzorci tal, uporabljeni v testih, morajo biti sveže odvzeti iz kmetijskih tal.
The sites from which soil is taken must not have been treated during the previous 2 years with any substance that could substantially alter the diversity and levels of microbial populations present, other than in a transitory manner.
Odvzemna mesta vsaj dve leti pred odvzemom ne smejo biti tretirana s snovjo, ki bi lahko bistveno spremenila raznovrstnost populacij in stopnje prisotnosti populacij mikroorganizmov, razen prehodno.
Effects on other non-target organisms (flora and fauna) believed to be at risk
Vplivi na druge neciljne organizme (flora in favna), ki bi lahko bili ogroženi
A summary of available data from preliminary tests used to assess the biological activity and dose range finding, whether positive or negative, which may provide information with respect to possible impact on other 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 o možnem vplivu na neciljne vrste.
Effects on biological methods for sewage treatment
Vplivi na biološke metode v postopkih čiščenja odpadnih vod
Effects on biological methods for sewage treatment must be reported where the use of plant protection products containing the active substance can give rise to adverse effects on sewage treatment plants.
Kadar lahko uporaba fitofarmacevtskih sredstev, ki vsebujejo aktivno snov, škodljivo vpliva na biološke postopke čiščenja odpadnih vod, je treba navesti podatke o teh vplivih.
Summary and evaluation of Sections 7 and 8
Povzetek in ocena oddelkov 7 in 8
Proposals including justification for the proposals for the classification and labelling of the active substance in accordance with Regulation (EC) No 1272/2008
Predlogi, vključno z utemeljitvijo predlogov za razvrščanje in označevanje aktivne snovi v skladu z Uredbo (ES) št. 1272/2008
Pictogram(s)
piktogrami
Signal words
opozorilne besede
Hazard statements
stavki o nevarnosti
Precautionary Statements.
previdnostni stavki
A dossier as referred to in Part A of the Annex to Regulation (EU) No 545/2011, for a representative plant protection product
Dokumentacija iz dela A Priloge k Uredbi (EU) št. 545/2011 za reprezentativno fitofarmacevtsko sredstvo
MICRO-ORGANISMS INCLUDING VIRUSES
MIKROORGANIZMI, VKLJUČNO Z VIRUSI
Active substances are defined in Article 2(2) of Regulation (EC) No 1107/2009 and include chemical substances and micro-organisms including viruses.
Aktivne snovi so opredeljene v členu 2(2) Uredbe (ES) št. 1107/2009 ter vključujejo kemijske snovi in mikroorganizme, vključno z virusi.
This Part provides data requirements for active substances consisting of micro-organisms, including viruses.
Ta del določa zahteve glede podatkov za aktivne snovi, ki so sestavljene iz mikroorganizmov, vključno z virusi.
The term ‘micro-organism’ as defined in Article 3 of Regulation (EC) No 1107/2009 applies to, but is not limited to, bacteria, fungi, protozoa, viruses and viroids.
Izraz „mikroorganizem“, kot je opredeljen v členu 3 Uredbe (ES) št. 1107/2009, se uporablja za, vendar ni omejen na, bakterije, glive, praživali, viruse in viroide.
For all micro-organisms that are subject to application all available relevant knowledge and information in literature should be provided.
Za vse mikroorganizme, na katere se nanaša vloga, je treba predložiti vsa razpoložljiva relevantna dognanja in informacije iz literature.
The most important and informative information is obtained by the characterisation and identification of a micro-organism.
Najpomembnejše in najbolj poučne informacije se pridobivajo z določanjem mikroorganizma in njegovih lastnosti.
Such information is found in Sections 1 to 3 (identity, biological properties and further information) which form the basis for an assessment of human health and environmental effects.
Takšne informacije so navedene v oddelkih 1 do 3 (identiteta, biološke lastnosti in nadaljnje informacije), ki tvorijo podlago za oceno vplivov na zdravje ljudi in na okolje.
Newly generated data from conventional toxicological and/or pathological experiments on laboratory animals are normally required unless the applicant can justify, on the basis of the previous information, that the use of the micro-organism, under the proposed conditions of use, does not have any harmful effects on human and animal health or on groundwater or any unacceptable influence on the environment.
Najnovejši podatki, pridobljeni na podlagi običajnih toksikoloških in/ali patoloških testov na laboratorijskih živalih, se običajno zahtevajo, razen če lahko vlagatelj na podlagi predhodnih informacij utemelji, da uporaba mikroorganizma pod predlaganimi pogoji uporabe nima nobenega škodljivega učinka na zdravje ljudi in živali ali podtalnico ali nobenega nedopustnega vpliva na okolje.
Pending the acceptance of specific guidelines at international level, the information required shall be generated using available test guidelines accepted by the competent authority (e.g. USEPA guideline [16]; where appropriate, test guidelines as described in Part A of this Annex should be adapted in such a way that they are appropriate for micro-organisms.
Do sprejetja posebnih smernic na mednarodni ravni se zahtevane informacije pridobivajo z uporabo razpoložljivih smernic za testiranje, ki jih sprejme pristojni organ (npr. smernice USEPA [16]). Kadar je to primerno, je treba smernice za testiranje, kakor so opisane delu A te priloge, prilagoditi tako, da so primerne za mikroorganizme.
Testing shall include viable and, if appropriate, non-viable micro-organisms, and a blank control.
Testiranje mora vključevati 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 point 1.4, must be provided.
Kadar se opravi test, je treba v skladu s točko 1.4 predložiti natančen opis (specifikacijo) uporabljene snovi in nečistoč, ki jih vsebuje.
The material used shall be of that specification that will be used in the manufacture of preparations to be authorised.
Sestava uporabljene snovi je takšna, kot se bo uporabljala pri proizvodnji pripravkov, ki so v postopku registracije.
Where studies are conducted using micro-organisms produced in the laboratory or in a pilot plant production system, the studies must be repeated using micro-organisms as manufactured, unless it can be demonstrated that the test material used is essentially the same for the purposes of the testing and assessment.
Kadar se študije izvedejo z uporabo mikroorganizmov, proizvedenih v laboratoriju ali v poskusni proizvodnji, je treba študije ponoviti z mikroorganizmi iz redne proizvodnje, razen če se lahko nazorno pokaže, da je uporabljena testna snov v bistvu enaka za namene testiranja in ocenjevanja.
Where the micro-organism has been genetically modified, a copy of the evaluation of the data concerning the assessment of risk to the environment, as stated in Article 48 to Regulation (EC) No 1107/2009, has to be submitted.
Kadar so mikroorganizmi gensko spremenjeni, je treba predložiti izvod ocene podatkov glede ocene tveganja za okolje, kot je določeno v členu 48 Uredbe (ES) št. 1107/2009.
Full details of the statistical analysis shall be reported (e.g. all point estimates shall be given with confidence intervals, exact p-values should be given rather than stating significant/non-significant).
Navedejo se vse podrobnosti statistične analize (npr. vse ocenjene vrednosti z intervalom zaupanja in natančne p-vrednosti namesto navajanja statistično značilno/neznačilno).
In the case of studies in which dosing extends over a period, dosing shall preferably be done using a single batch of the micro-organism, if stability permits.
Pri študijah, v katerih se odmerek nanaša večkrat v nekem obdobju, se po možnosti uporabi ista serija mikroorganizma, če njegova stabilnost to omogoča.
If the studies are not performed using a single batch of the micro-organism, the similarity of the different batches has to be stated.
Če se študije ne izvajajo z uporabo iste serije mikroorganizma, je treba navesti, da so si različne serije podobne.
If the plant protection action is known to be due to the residual effect of a toxin/metabolite or if significant residues of toxins/metabolites are to be expected not related to the effect of the active substance, a dossier for the toxin/metabolite has to be submitted in accordance with the requirements of Part A of this Annex,.
Če je znano, da je učinek fitofarmacevtskega sredstva posledica delovanja ostankov toksina/metabolita, ali se pričakujejo znatni ostanki toksinov/metabolitov, ki niso povezani z učinkovanjem aktivne snovi, je treba za ta toksin/metabolit predložiti dokumentacijo v skladu z zahtevami iz dela A te priloge.
Identity of the micro-organism
Identiteta mikroorganizma
The identification together with the characterisation of the micro-organism provides the most important information and is a key point for decision-making.
Ime in lastnosti mikroorganizma zagotavljajo najpomembnejše informacije in so ključnega pomena za odločanje.
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 to which the application for approval is submitted, and if different, in the rapporteur Member State appointed by the Commission, the name and address of the local office, agent or representative must be provided, as must 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 vloži vlogo za odobritev, z drugačnim naslovom od naslova v državi članici poročevalki, ki jo imenuje Komisija, je treba navesti ime in naslov lokalne poslovalnice, zastopnika ali predstavnika ter ime, položaj, telefonsko številko in številko telefaksa ustrezne kontaktne osebe.
The name and address of the producer or producers of the micro-organism must be provided as must the name and address of each plant in which the micro-organism is produced.
Navesti je treba ime in naslov proizvajalca ali proizvajalcev mikroorganizma ter ime in naslov vsakega proizvodnega obrata, v katerem se mikroorganizem proizvaja.
A contact point (preferably a central contact point, to include name, telephone and fax number) must be provided, with a view to providing updating information and responding to queries arising, regarding production technology, processes and the quality of product (including where relevant, individual batches).
Navesti je treba kontaktno točko (po možnosti osrednjo kontaktno točko, ki vključuje ime, telefonsko številko in številko telefaksa) za posredovanje posodobljenih informacij in reševanje vprašanj v zvezi s proizvodno tehnologijo, procesi in kakovostjo proizvoda (vključno s posameznimi serijami, kjer je to relevantno).
Where, following approval of the micro-organism, there are changes in the location or number of producers, the information required must again be notified to the Commission and the Member States.
Kadar se po odobritvi mikroorganizma spremeni lokacija ali število proizvajalcev, je treba zahtevane informacije ponovno posredovati Komisiji in državam članicam.
The micro-organism should be deposited at an internationally recognised culture collection and given an accession number and these details must be submitted.
Mikroorganizem mora biti shranjen pri mednarodno priznani zbirki kultur in opremljen s pristopno številko, te podrobnosti pa morajo biti navedene.
Each micro-organism that is subject to the application shall be identified and named at the species level.
Vsak mikroorganizem, ki je predmet vloge, se opredeli in imenuje na ravni vrste.
The scientific name and taxonomic grouping, i.e. family, genus, species, strain, serotype, pathovar or any other denomination relevant to the micro-organism, must be stated.
Navesti je treba znanstveno ime in taksonomsko skupino, tj. družina, rod, vrsta, sev, serotip, patovar ali katero koli drugo imenovanje, ki ustreza mikroorganizmu.
It must be indicated whether the micro-organism:
Navesti je treba, ali je mikroorganizem:
is indigenous or non-indigenous at the species level to the intended area of application,
na ravni vrste avtohton ali neavtohton na predvidenem območju uporabe,
is a wild type,
divja oblika,
is a spontaneous or induced mutant,
spontan ali induciran mutant,
has been modified, using techniques described in Part 2 of Annex IA and in Annex IB to Directive 2001/18/EC of the European Parliament and of the Council [17].In the latter two cases, all known differences between the modified micro-organism and the parent wild strain must be provided.
spremenjen z uporabo tehnik iz dela 2 Priloge IA in Priloge IB k Direktivi 2001/18/ES Evropskega parlamenta in Sveta [17].V zadnjih dveh primerih je treba navesti vse znane razlike med spremenjenim mikroorganizmom in starševskim divjim sevom.
Best available technology should be used to identify and characterise the micro-organism at the strain level.
Za opredelitev mikroorganizma in določitev njegovih lastnosti na ravni seva je treba uporabiti najboljšo razpoložljivo tehnologijo.
The appropriate test procedures and criteria used for identification (e.g. morphology, biochemistry, serology, molecular identification) must be provided.
Zagotoviti je treba primerne testne postopke in merila, uporabljena za opredelitev (npr. morfološka, biokemijska, serološka, molekularna identifikacija).
Common name or alternative and superseded names and code names used during the development, if any, must be provided.
Navesti je treba splošno ali alternativno ime ter nadomestna in kodna imena, če obstajajo kakšna, ki se uporabljajo med razvojem.
Relationships to known pathogens shall be indicated.
Navedejo se sorodnosti z znanimi patogeni.
Content of the micro-organism
Vsebnost mikroorganizma
The minimum and maximum content of the micro-organism in the material used for manufacturing of formulated products, must be reported.
Navesti je treba najnižjo in najvišjo vsebnost mikroorganizma v snovi, uporabljeni za proizvodnjo formuliranih proizvodov.
The content shall be expressed in appropriate terms, such as number of active units per volume or weight or any other manner that is relevant to the micro-organism.
Vsebnost se izrazi v primernih enotah, kot so število aktivnih enot na volumen ali težo ali kateri koli drugi način, ki ustreza mikroorganizmu.
It is desirable to have a plant protection product without contaminants (including contaminating micro-organisms), if possible.
Zaželeno je, da fitofarmacevtsko sredstvo ne vsebuje kontaminantov (vključno s kontaminantnimi mikroorganizmi), če je mogoče.
The level and nature of acceptable contaminants shall be judged from a risk assessment point of view, by the competent authority.
Stopnjo in naravo dopustnih kontaminantov presodi pristojni organ z vidika ocene tveganja.
If possible and appropriate, the identity and maximum content of all contaminating micro-organisms, expressed in the appropriate unit, must be reported.
Če je to mogoče in primerno, je treba navesti ime in najvišjo vsebnost vseh kontaminantnih mikroorganizmov v primernih enotah.
The information on identity must be provided where possible as outlined in point 1.3 of Part B of this Annex.
Informacije o identiteti je treba, kadar je to mogoče, navesti, kot je opisano v točki 1.3 dela B te priloge.
Relevant metabolites (i.e. if expected to be of concern to human health and/or the environment) known to be formed by the micro-organism shall be identified and characterised at different states or growth stages of the micro-organism (see point (viii) of the introduction to this Part).
Relevantni metaboliti (tj. če se pričakuje zaskrbljenost za zdravje ljudi in/ali varstvo okolja), za katere je znano, da jih povzročajo mikroorganizmi, in njihove lastnosti se opredelijo na različnih stopnjah rasti ali razvoja mikroorganizma (glej točko (viii) uvoda k temu delu).
Where relevant detailed information on all components such as condensates, culture medium, etc. must be provided.
Kadar je to relevantno, je treba navesti podrobne informacije o vseh sestavinah, kot so npr. kondenzati, kulture gojišča itd.
In the case of chemical impurities that are relevant for human health and/or the environment, the identity and maximum content, expressed in appropriate terms, must be provided.
V primeru kemijskih nečistoč, ki so relevantne za zdravje ljudi in/ali za okolje, je treba navesti njihovo ime in največjo vsebnost v primernih enotah.
In the case of additives, the identity and content in g/kg must be provided.
V primeru dodatkov je treba navesti ime in vsebnost v g/kg.
The information on identity of chemical substances such as additives must be provided as outlined in point 1.10 of Part A of this Annex.
Informacije o imenu kemijskih snovi, kot so dodatki, je treba navesti, kot je opisano v točki 1.10 dela A te priloge.
Where relevant, the same data as outlined in point 1.11 of Part A of this Annex have to be reported, using the appropriate units.
Kadar je relevantno, je treba navesti enake podatke, kot so opisani v točki 1.11 dela A te priloge, ob uporabi primernih enot.
Natural occurrence and geographical distribution
Naravna prisotnost in geografska razširjenost
Familiarity, interpreted as the availability of relevant knowledge of the micro-organism, shall be presented.
Predstavi se poznavanje, ki se razlaga kot razpoložljivost relevantnih dognanj o mikroorganizmu.
The historical background of the micro-organism and its use (tests/research projects or commercial use) must be provided.
Navesti je treba zgodovinsko ozadje mikroorganizma in njegove uporabe (testi/raziskovalni projekti ali uporaba v komercialne namene).
Origin and natural occurrence
Izvor in naravna prisotnost
The geographical region and the place in the ecosystem (e.g. host plant, host animal, or soil from which the micro-organism was isolated) must be stated.
Navesti je treba geografsko regijo in mesto v ekosistemu (npr. rastlina gostiteljica, žival gostiteljica ali tla, iz katerih je bil mikroorganizem izoliran).
The method of isolation of the micro-organism shall be reported.
Navede se postopek izolacije mikroorganizma.
The natural occurrence of the micro-organism in the relevant environment shall be given if possible at strain level.
Če je to mogoče, se naravna prisotnost mikroorganizma v ustreznem okolju navede na ravni seva.
In the case of a mutant, or a genetically modified micro-organism, detailed information should be provided on its production and isolation and on the means by which it can be clearly distinguished from the parent wild strain.
V primeru mutanta ali gensko spremenjenega mikroorganizma, je treba navesti podrobne informacije o njegovem pridobivanju in izolaciji ter načinu, po katerem se ga lahko jasno razlikuje od starševskega divjega seva.
Information on target organism(s)
Informacije o ciljnih organizmih
Description of the target organism(s)
Opis ciljnih organizmov
The principal mode of action shall be indicated.
Navede se glavni način delovanja.
In connection with the mode of action it shall also be stated if the micro-organism produces a toxin with a residual effect on the target organism.
V zvezi z načinom delovanja se navede tudi, ali mikroorganizem proizvaja toksin s stranskim učinkom na ciljnem organizmu.
In that case, the mode of action of this toxin shall be described.
V tem primeru se opiše način delovanja tega toksina.
If relevant, information on the site of infection and mode of entry into the target organism and its susceptible stages shall be given.
Če je relevantno, se navedejo informacije o mestu okužbe in načinu vnosa v ciljni organizem ter fazah njegove dovzetnosti.